Coronavirus information for Feinberg.

Skip to main content

Clinical Trials

As part of an academic medical center, the Department of Medicine at Northwestern University Feinberg School of Medicine aims to improve the human health through scientific research.

About Clinical Trials

Clinical trials test or study drugs, surgical procedures, medical devices or interventions with human subjects. They look to determine their safety and effectiveness in relation to treating specific diseases. Clinical trials are part of clinical research and are at the heart of all medical advances.

Department of Medicine Clinical Trials

The following searchable list includes all Department of Medicine clinical trials currently looking for participants.

Contact Us

Please feel free to contact us with inquiries about any of our ongoing research.

Trials
INtervention Study In OverweiGHT Patients with COPD (INSIGHT COPD)
We are conducting the INSIGHT COPD study because symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap. There are many medications for patients with COPD, but there is little mention of weight…
We are conducting the INSIGHT COPD study because symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap. There are many medications for patients with COPD, but there is little mention of weight loss as a possible treatment in current research. We are trying to find out if a lifestyle program that promotes modest weight loss and increased physical activity will improve COPD symptoms for those with a high BMI. We hope that the program will lead to weight loss and better exercise tolerance. We are also looking at the effects on shortness of breath, quality-of-life, and cardiovascular disease risk factors.

1 year, 2 visits.

40 years of age or older with COPD, wants to participate in a healthy lifestyle intervention, body mass index of 25 -44.9
Kalhan, RaviKalhan, Ravi
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02634268 STU00204332
More Info
Copy
Losartan Effects on Emphysema Progression (LEEP)
This research is being done to look at how a medicine called Losartan helps people with Chronic Obstructive Pulmonary Disease (COPD) with emphysema – a disease of the lungs. COPD is often caused by cigarette smoking. It includes the symptoms…
This research is being done to look at how a medicine called Losartan helps people with Chronic Obstructive Pulmonary Disease (COPD) with emphysema – a disease of the lungs. COPD is often caused by cigarette smoking. It includes the symptoms of emphysema and chronic bronchitis. Although some medications for COPD reduce symptoms and prevent exacerbations, few medications have been shown to reduce the damage to the lungs in people with COPD. Losartan is a medicine used for treatment of high blood pressure. Losartan has been shown to slow the damage to lungs caused by COPD in animals. We would like to find out if taking Losartan can slow the damage to lungs caused by COPD. We will use images of participants’ lungs taken with high resolution computed tomography (HRCT) to measure changes in the lung. We also want to find out if Losartan has effects on blood and breathing tests.
40 years of age or older with COPD, controlled blood pressure, no flare of COPD in the last 6 weeks or the use of antibiotics or prednisone
Kalhan, RaviKalhan, Ravi
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02696564 STU00204797
More Info
Copy
REdefining THerapy IN early COPD

The purpose of this study is toevaluate a drug called indacterol/glycopyrrolate that may help improve yourbreathing. Indacterol/glycopyrrolate is an inhaled medication that is an FDAapproved medication for people who have Chronic Obstructive Pulmonary Disease(COPD)…

The purpose of this study is toevaluate a drug called indacterol/glycopyrrolate that may help improve yourbreathing. Indacterol/glycopyrrolate is an inhaled medication that is an FDAapproved medication for people who have Chronic Obstructive Pulmonary Disease(COPD). It is being used as an investigational drug in this study in people whodo not meet the current criteria for COPD but have respiratory symptoms (suchas coughing and shortness of breath).

12 weeks, 2 visits and 1 phone call.

Age 40-80

Current or former smoker

With symptoms of shortness of breath, chest tightness, cough, wheeze, and limitation in activities.

Kalhan, RaviKalhan, Ravi
NCT02867761 STU00204372
More Info
Copy
xIRB A Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study of Intravenous ATYR1923 in Patients with Pulmonary Sarcoidosis

This study is being done to learn more about the safety ofan experimental drug called ATYR1923 to see if taking this medication willallow people who have…

This study is being done to learn more about the safety ofan experimental drug called ATYR1923 to see if taking this medication willallow people who have pulmonary sarcoidosis to reduce their steroid dose, andto find out more about the effects of different doses of this drug on the lungsof people who have pulmonary sarcoidosis. This study will also look at how thebody responds to the drug. These things will be measured by taking samples ofblood, performing medical examinations, conducting lung function tests andreviewing images of the lungs.

In this study, people with pulmonary sarcoidosis willreceive monthly doses of ATYR1923 or Placebo for a total of 6 doses.Participation will last up to 28 weeks. The screening period to see if youqualify for the study may last up to 4 weeks and may require up to 3 visits atthe study site clinic. Participants who enter the study will receive study drugonce a month for 20 weeks. The study drug will be administered by infusion andeach visit will take approximately 6 hours. There are a total of 7 study clinicvisits and 8 telephone contacts during the treatment period. Finally, there will be a follow-up studyvisit 4 weeks after receiving the last dose of study drug.

To qualify for the study you must be:

1. Diagnosed with pulmonary sarcoidosis for at least 1year

2. Taking 10 to 25 mg/day of oral prednisone (or oralequivalent), at the same dose for at least 4 weeks before receivingstudy drug.

You will not qualify for the study if you have:

1. Cardiac, neurological, gastrointestinal, and/or renalmanifestations of sarcoidosis

2. Received treatment with biological medications (such asinfliximab (REMICADE) or adalimumab (HUMIRA) in the last 6 months

3. Smoked or inhaled (including e-cigarettes ore-vaporizers) any nicotine containing product within 6 months prior toScreening visit.

4. History of or positive results of hepatitis B, hepatitisC, or HIV

5. Jo-1 Antibody levels >7 U/mL, or past history of Jo-1antibody positivity.

Sporn, Peter HSporn, Peter H
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03824392 STU00208847
More Info
Copy
The Effect of KNO3 Compared to KCl on Oxygen Uptake in Heart Failure with Preserved Ejection Fraction
KNO3CK-OUT HFpEF: This study is enrolling participants with a diagnosis of heart failure with preserved ejection fraction (HFpEF). This is a condition that causes patients to be short of breath and l…
KNO3CK-OUT HFpEF: This study is enrolling participants with a diagnosis of heart failure with preserved ejection fraction (HFpEF). This is a condition that causes patients to be short of breath and limited in what they can do in their daily lives. Currently, there are no approved drugs for this condition. Researchers are trying to find new therapies for this condition. The purpose of this study is to test whether Potassium Nitrate (KNO3) will improve how people with HFpEF can exercise. In HFpEF, patients are limited in their ability to do all the things they want to do, and exercise as much as they would like, due to becoming tired and short of breath early. We do not know exactly why these limitations occur. There is some evidence that in addition to problems with the heart, patients with HFpEF also have problems with their arteries and muscles that affect their ability to exercise. Potassium Nitrate has been shown to improve how muscles work and also improve blood flow to working muscles in the body in healthy individuals. We previously conducted a pilot study with our KNO3 pills and found them to be safe in subjects with HFpEF. We would like to now study our pills in a large study to see if we can improve exercise in HFpEF. The use of Potassium Nitrate in this study is investigational. Potassium Nitrate has not been approved by the Food and Drug Administration (FDA) for the use being evaluated in this study.
Shah, Sanjiv JShah, Sanjiv J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02840799 STU00202379
More Info
Copy
A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve
This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (TH…
This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) Model 9600TFX and associated delivery systems for the aortic valve in valve procedure. Participants in this study will have the investigational (experimental) Edwards SAPIEN 3 transcatheter aortic heart valve (study device) to replace the failing bioprosthetic aortic valve access through the heart through a small incision is in the chest. The study device and its delivery system are investigational, which means they are not approved for commercial use by the U.S. Food and Drug Administration (FDA) for the valve in bioprosthetic valve procedure. The previous generation of SAPIEN valves, SAPIEN XT, was approved for commercial use by the FDA for a failed surgical bioprosthetic aortic valve in October 2015. The study device is a bioprosthetic heart valve made out of man-made materials and animal tissue. It is an artificial device made to replace the diseased aortic heart valve. Each valve consists of a stent (mesh tube made of metal) to hold the study device in its intended position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in the heart. Study participation will last approximately 10 years. Participants will be asked to come to clinic for study visits at 30 days, 6 months, and 12 months after the study procedure and then annually until 10 years after the procedure. We expect up to 19 people will be enrolled at Northwestern. The study expects to enroll up to 125 people internationally.
*Main Inclusion Criteria*
Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.

*Main Exclusion Criteria*
Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion).
Severe regurgitation (>3+) or stenosis of any other valve.
Failing valve is unstable, rocking, or not structurally intact.
Malaisrie, S ChrisMalaisrie, S Chris
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03003299 STU00204739
More Info
Copy
Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients with AsYmptomatic Severe Aortic Stenosis: EARLY TAVR trial
The main reason for the study is to determine whether aortic valve replacement with the Edwards SAPIEN 3 THV (the “Study Device”) is helpful for pa…
The main reason for the study is to determine whether aortic valve replacement with the Edwards SAPIEN 3 THV (the “Study Device”) is helpful for patients who have severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms. The Study Device is a bioprosthetic heart valve. It is an artificial device made to replace your diseased aortic heart valve. Each valve consists of a stent (mesh tube made of metal) to hold the valve in position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in your heart. The Study Device and its delivery system are not approved for commercial use by the U.S. Food and Drug Administration (FDA) in patients that do not have symptoms of aortic stenosis. To date, more than 12,000 patients have been enrolled in clinical studies with an Edwards THV. The SAPIEN 3 THV that is being investigated for this study has been implanted in over 3,000 patients with symptoms of severe aortic stenosis and has been approved by FDA for those patients. Participation in the study will vary, depending upon the treatment group you are assigned. If you are in the TAVR group, your participation will be for 5 years. If you are in the Clinical Surveillance group, your participation could range from 5 to 10 years. If you are in the registry group, your participation will be for 5 years. We expect up to 166 people will participate in the main study and up to up to 150 in the registry here at Northwestern. A total of 1109 patients will participate in the main study and up to 1000 patients will participate in the registry internationally.
Inclusion Criteria:
Severe aortic stenosis
Patient is asymptomatic
The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board of the respective clinical site.

Exclusion Criteria:
Patient is symptomatic.
Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
Aortic valve is a unicuspid, bicuspid, or is non-calcified.
Severe aortic regurgitation (>3+).
Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis.
Davidson, Charles JDavidson, Charles J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03042104 STU00204517
More Info
Copy
A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Mitral Bioprosthetic Valve
This study is enrolling patients whose existing bioprosthetic mitral valve is failing and needs to be repla…
This study is enrolling patients whose existing bioprosthetic mitral valve is failing and needs to be replaced and who are considered at intermediate risk for open heart surgery. This research study will evaluate the safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve (THV) in patients with a failing mitral bioprosthetic valve. Transcatheter valve replacement is a catheter-based technique for replacing the failing valve, which is less invasive than open-heart surgery.
This study will enroll patients with symptomatic heart disease due to a failing bioprosthetic mitral valve (stenosed, insufficient, or combined)
Malaisrie, S ChrisMalaisrie, S Chris
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03193801 STU00205381
More Info
Copy
AF STOP: AF Substrate as an Outcome and Predictor of successful AF ablation
To improve the understanding of factors associated with the atrial myopathy in people with AF or people at risk for developing AF
Primary Inclusion Criteria:
  • Patients ≥ 18 years old
  • Patients with paroxysmal or early persistent AF undergoing routine pulmonary vein isolation (PVI)
  • Subjects who are scheduled to undergo clinically ordered cardiac MRI for planning of AF ablation

Primary Exclusion Criteria:

  • Longstanding persistent AF (continuous AF > 1 year) or AF from a reversible cause
  • Previous catheter or surgical ablation for AF
  • Contraindication to MRI
  • Advanced chronic renal insufficiency (GFR < 30 mL/min/1.73 m2), anemia (hemoglobin < 10 g/dL) or thrombocytopenia (platelet count < 100K/UL)
  • History of pulmonary emboli, CVA or TIA (within the past 6 months), atrial clot/thrombus on imaging, or blood clotting/bleeding abnormalities
Passman, Rod SPassman, Rod S
  • Map it 201 E. Huron St.
    Chicago, IL
STU00207885
More Info
Copy
Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with mitral regurgitation
The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System for transcatheter mitral valve repair compared to the MitraClip system in the treatment of patients with symptomatic degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team.

Primary Inclusion Criteria:

  • Patient is determined to be at prohibitive risk for mitral valve surgery by a heart team
  • Mitral regurgitation (3+ to 4+) by echo (TTE or TEE) as measured by the core lab
  • Left ventricular ejection fraction (LVEF) ≥ 20%
  • Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03706833 STU00208635
    More Info
    Copy
    Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure: a randomized trial (TAVR UNLOAD)

    The purpose of this study is to evaluate the use of a device to treat patients with Heart Failure (HF - inability of the heart to pump enough blood to m…

    The purpose of this study is to evaluate the use of a device to treat patients with Heart Failure (HF - inability of the heart to pump enough blood to meet the body's needs) who have moderate aortic stenosis (AS - narrowing of the aortic valve resulting in obstructed blood flow). This clinical trial is comparing the safety and effectiveness of TAVR (Transcatheter Aortic Valve Replacement) with the Edwards SAPIEN 3 Transcatheter Heart Valve (the Study Valve) and OHFT (optimal heart failure therapy) versus OHFT alone in HF patients with moderate AS. The study valve has not been approved by the U.S. Food and Drug Administration (FDA) for use in this patient population, and therefore it's use in this study is considered investigational.
    This study is looking for patients with Heart Failure and moderate Aortic Stenosis. Aortic Stenosis is a narrowing of the aortic valve opening,which blocks blood flow from the heart and causes symptoms such as chest pain,fainting and shortness of breath.
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02661451 STU00208415
    More Info
    Copy
    SUPERIOR VENA CAVAL OCCLUSION IN SUBJECTS WITH ACUTE DECOMPENSATED HEART FAILURE- AN EARLY FEASIBILITY STUDY
    This study is enrolling patients who have Acute Decompensated Heart Failure (ADHF) and are having or recently had a cardiac catheterization procedure as part of their clinical care (not part o…
    This study is enrolling patients who have Acute Decompensated Heart Failure (ADHF) and are having or recently had a cardiac catheterization procedure as part of their clinical care (not part of the research).The reason we are doing this research study is to look at the preCARDIA device (the “study device”) to see if it can help treat Advanced Heart Failure. This type of research study is called an “early feasibility study”. Early feasibility studies typically evaluate innovative devices or innovative uses of approved devices. These studies enroll a small number of participants and provide initial information on the basic safety and performance of the study device when used to treat a specific patient type. The study device is investigational and not approved by the US Food and Drug Administration (FDA) for your medical condition. In patients with advanced heart failure, specifically severely congested patients with Acute Decompensated Heart Failure (ADHF), poor heart function leads to an excess of fluid in the right side of the heart (“fluid overload”) and symptoms such as shortness of breath. Drugs such as diuretics are designed to improve these symptoms and heart function by reducing fluid overload. However, diuretics take time to work and may be ineffective in patients with advanced heart failure, a phenomenon known as diuretic resistance. For this reason, a device-based approach designed to limit fluid overload is being studied to see if it could possibly improve symptoms and heart function in congested patients with advanced heart failure. The study device will temporarily block (“occlude”) one of the veins that return blood to the heart in order to potentially reduce fluid buildup and potentially improve the heart’s pumping function temporarily.
    Benzuly, Keith HBenzuly, Keith H
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03836079 STU00210029
    More Info
    Copy
    Utility of Esophageal Temperature Management for the Prevention of Thermal Injury During Cryoballoon Ablation for Atrial Fibrillation
    This study is enrolling patient who have an irregular heart rhythm called atrial fibrillation (AF) and are scheduled for a first-time AF ablation procedure to treat th…
    This study is enrolling patient who have an irregular heart rhythm called atrial fibrillation (AF) and are scheduled for a first-time AF ablation procedure to treat their AF. Current techniques used during AF ablation procedures to try and reduce potential damage to the esophagus during ablation are limited. The purpose of this study is to determine if esophageal warming using the Attune Medical Esophageal Heat Transfer Device (ensoETM) limits the injury to the esophagus during atrial fibrillation ablation procedures. The ensoETM is an FDA approved device used for temperature management, but is not routinely used during atrial fibrillation ablation procedures.
    Verma, NishantVerma, Nishant
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT04079634 STU00209610
    More Info
    Copy
    The “RADIANCE II” Pivotal Study A Study of the ReCor Medical Paradise System in Stage II Hypertension
    This study is enrolling patients who have high blood pressure ("hypertension") and are taking two medications or fewer for it. It is believed that in some patients with high blood pressure, the n…
    This study is enrolling patients who have high blood pressure ("hypertension") and are taking two medications or fewer for it. It is believed that in some patients with high blood pressure, the nerves surrounding the blood vessels leading to the kidneys (renal arteries) are too active and that this may be causing high blood pressure. Renal denervation is a procedure where a catheter is placed inside these blood vessels and creates heat to disable the nerves and potentially lower blood pressure. The purpose of this clinical study is to see whether a medical device called the Paradise Renal Denervation System (also called The Paradise System) can lower high blood pressure in patients who are known to have hypertension.
    Benzuly, Keith HBenzuly, Keith H
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03614260 STU00209790
    More Info
    Hypertension HTN
    Copy
    Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation
    This study is enrolling patients with severe Tricuspid Regurgitation (TR), a condition in the heart’s tricuspid valve does not close tightly which causes the blood to flow in the wrong direction. The standard medical treatments generally available to patients with tricuspid regurgitation who do not undergo surgery, may temporarily alleviate some symptoms, but will not permanently alleviate or cure tricuspid regurgitation.  The goal of this trial is to evaluate the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System (hereinafter referred to as the PASCAL System) with optimal medical therapy (OMT) compared to OMT alone in the treatment of participants with symptomatic severe tricuspid regurgitation who may not be ideal candidates for tricuspid valve surgery (performed via open-heart surgery) and may be eligible for transcatheter tricuspid valve repair (minimally invasive procedure that repairs the valve). Optimal Medical Therapy (OMT) refers to standard of care treatment using recommended medications
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04097145 STU00211052
    More Info
    Copy
    Right Ventricular Ischemia and Fibrosis in Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
    This study is enrolling patients who have been diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) and who are scheduled for a pulmonary endareterectomy (PEA) or balloon pulmonary angiopl…
    This study is enrolling patients who have been diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) and who are scheduled for a pulmonary endareterectomy (PEA) or balloon pulmonary angioplasty (BPA) procedure for treatment. CTEPH is high blood pressure in the arteries in the pulmonary system (lungs) caused by clots. Over time the clots typically leave scar tissue (fibrosis) in the arteries and lead to poor blood supply to the heart. In patients with CTEPH symptoms of heart failure commonly result from dysfunction (not working correctly) in the right ventricle (RV), or the chamber of the heart that pumps blood to the lungs. However, little is currently known about why or how that chamber of the heart becomes dysfunctional in patients with this condition. In another chamber of the heart, the left ventricle, it is known that elevated blood pressure in that chamber causes the development of diffuse fibrosis, or scarring between the muscle fibers, and a similar process may take place in the right ventricle of patients with CTEPH.

    For this study a cardiac magnetic resonance imaging (MRI) stress test (also known as stress CMR) will be done to look at the RV in patients with CTEPH before and 6 months after treatment. A stress CMR is a specialized scan of the heart that examines fibrosis (scarring) and blood flow (perfusion) both at rest and under stress. A gadolinium contrast agent (MRI dye) is given to highlight the heart muscle in areas receiving a good blood supply. Areas receiving less blood do not highlight as well as the good areas, which can be an indicator of ischemic heart disease (undersupply of blood and oxygen to the heart).

    Freed, Benjamin HowardFreed, Benjamin Howard
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    STU00210998
    More Info
    Copy
    pHysiological signals, Activity and Posture for surface mounted Insertable Cardiac Monitor in Heart Failure (HAPI-HF) Study
    This study is enrolling patients to use a wearable insertable cardiac monitor to better understand the various sounds that the heart makes during cardiac tests. You are being as…
    This study is enrolling patients to use a wearable insertable cardiac monitor to better understand the various sounds that the heart makes during cardiac tests. You are being asked to participate in this study because Boston Scientific Corporation (BSC) is making a device called the insertable cardiac monitor (ICM) that measures certain heart functions. The device also works when it is placed on top of the chest. BSC made a more comfortable, wearable version of the device to use in this study. The wearable device is called the wearable cardiac monitor (WCM). As part of the study, the WCM will collect data during tests while taped to the skin. The tests include leg raise exercises, lying down, sitting and/or standing, and an optional submaximal exercise test for participants the study doctor determines appropriate. There may also be an echocardiogram during these tests. An echocardiogram takes pictures of the heart using sounds waves created by the heart. The purpose of this study is to collect data during a series of tests to see if the WCM can detect signals related to heart failure. This data will be compared to the data obtained by the echocardiogram.
    Shah, Sanjiv JShah, Sanjiv J
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04112576 STU00210829
    More Info
    Copy
    Percutaneous MitraClipTM Device or Surgical Mitral Valve REpair in PAtients with PrImaRy Mitral Regurgitation who are Candidates for Surgery (REPAIR MR)
    The purpose of this research study is to compare health outcomes of patients diagnosed with Primary MR who have their MV repaired with open heart su…
    The purpose of this research study is to compare health outcomes of patients diagnosed with Primary MR who have their MV repaired with open heart surgery, which is the current standard treatment, to patients who have their Mitral Valve repaired with the MitraClip System. The MitraClip System uses a less invasive procedure to repair the mitral valve.

    Subjects are asked to participate in this Study because they have moderate-to-severe or severe MR and it has been determined to have symptoms due to heart failure despite being treated with currently available therapies. MR occurs when the leaflets of the mitral valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart needs to pump more blood with each beat to push the same amount of blood forward.

    The Study will enroll approximately 500 subjects at up to 60 sites in Europe, United States, and Canada. The Study consists of two arms: Device Arm and Control Arm.

    • Subject has severe (Grade III or greater per the ASE criteria, which includes severitygrades of 3+ and 4+) primary MR (mixed etiology is acceptable provided theprincipal mechanism of action is a degenerative mitral valve) as assessed bythe ECL.
    • Subject is at least 75 years of age

    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04198870 STU00211557
    More Info
    Copy
    Clinical Trial to Evaluate Cardiovascular Outcomes in Patients Treated with the Tricuspid Valve Repair System Pivotal (TRILUMINATE Pivotal)
    The purpose of this research study is to compare the safety and effectiveness of an investigational tricuspid valve repair system, called TriClip TM Device, whic…
    The purpose of this research study is to compare the safety and effectiveness of an investigational tricuspid valve repair system, called TriClip TM Device, which is inserted into the heart, along with using optimal drug therapy for your heart condition versus optimal drug therapy alone. The Study will enroll approximately 700 subjects at up to 80sites in Europe, United States and Canada. Up to 50 participants will be enrolled at Northwestern. The Study is made up of three different groups: Randomized(up to 450), Roll-In (up to 150, and Single-Arm Registry (up to 100).
    • Age ≥18 years at time of consent.
    • Subject has been diagnosed with moderate or greater tricuspid regurgitation determined to have symptoms due to heart failure despite being treated with currently available therapies
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03904147 STU00210487
    More Info
    Copy
    A Multi-Center, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK­3773274 in Adults with Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction
    This study is enrolling pa…
    This study is enrolling patients who have obstructive hypertrophic cardiomyopathy (oHCM). Obstructive HCM is a condition in which the heart muscle in the left ventricle (LV) becomes abnormally thickened, which can block blood flow out of the heart to the body. This obstruction causes the LV heart muscle to work harder to pump blood to the body and can cause symptoms of chest pain, dizziness, shortness of breath and fainting. This is the first time the investigational drug called CK-3773274 is being studied in participants who have oHCM, but it has already been studied in healthy volunteers. The purpose of this study is to learn how well CK-3773274 is tolerated at different, increasing dose levels in patients with oHCM and if it causes any side effects. The study will also measure the amount of CK-3773274 in your blood at various times, and the effect the study drug may have on your oHCM. CK-3773274 is an investigational (experimental) study drug. This means that CK-3773274 has not been approved by the U.S. Food and Drug Administration (FDA) for use outside of a research study.
    Choudhury, LubnaChoudhury, Lubna
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04219826 STU00211491
    More Info
    Copy
    A Phase 3 Global, Double-Blind, Randomized, Placebo‑Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Transthyretin‑Mediated Amyloid Cardiomyopathy (ATTR CM)
    This study is enrolling patients who have transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) which i…
    This study is enrolling patients who have transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) which is a disease caused by change in a protein called transthyretin (TTR). This change can either be sporadic which is known as wild-type (wtATTR-CM) or due to a mutation of the TTR gene which is hereditary (hATTR-CM). In both cases, these changes can cause the TTR to clump and build up in certain parts of the body such as the nervous system, stomach, intestines, and heart. This build up is called an amyloid deposit. Amyloid deposits can sometimes cause heart disease or neuropathy (nerve damage). When amyloid is deposited into the heart, it can result in a condition referred to as cardiomyopathy. ION-682884 is an investigational drug. “Investigational” means that ION-682884 is not yet approved for use in any settings outside of clinical research studies like this one and is considered experimental. ION-682884 reduces the level of TTR in the blood of animals and healthy volunteers tested to date. Reducing the amount of TTR in the blood may reduce the amount of amyloid deposits in the body and may keep cardiomyopathy from getting worse over time. However, it is not known if ION-682884 will help cardiomyopathy. The purpose of this study is to evaluate the safety of ION-682884 and determine if it can help people with this type of cardiomyopathy.
    Shah, Sanjiv JShah, Sanjiv J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04136171 STU00211443
    More Info
    Copy
    Targeting Inflammation and Alloimmunity in Heart Transplant Recipients with Tocilizumab

    This study is enrolling patients who are about to have a heart transplant. After transplantation, or any other major surgery, there will be inflammation in the body. This inflammation can contribute to rejectio…

    This study is enrolling patients who are about to have a heart transplant. After transplantation, or any other major surgery, there will be inflammation in the body. This inflammation can contribute to rejection of the transplanted heart. In addition, the immune system (your body’s defenses to protect against disease) will be activated by the presence of the new heart. Investigators believe that a drug called tocilizumab (ACTEMRA®) might reduce or prevent inflammation and reduce the immune system’s response to the new heart, and that this would improve the long-term health of your new heart. The purpose of this research study is to see if a study drug called Actemra® (tocilizumab) will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant. Tocilizumab is a prescription medicine approved by the US Food and Drug Administration (FDA) to treat rheumatoid arthritis (RA) and other inflammatory diseases. Tocilizumab has not been used before to treat people who receive a heart transplant. We don’t know if it will be good for people who have a heart transplant. Tocilizumab is not approved by the FDA to treat heart transplant patients, and therefore using it in this study is considered investigational.

    Ghafourian, KambizGhafourian, Kambiz
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03644667 STU00212222
    More Info
    Copy
    Study To antagOnize Plasminogen Activator Inhibitor-1 in Severe COVID-19 (STOP Severe COVID-19)
    This study is enrolling patients at Northwestern Memorial Hospital who have tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) or coronavirus disease 2019 (COVID-19) and requir…
    This study is enrolling patients at Northwestern Memorial Hospital who have tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) or coronavirus disease 2019 (COVID-19) and require oxygen support. Doctors at Northwestern University want to better understand if blocking a molecule in the blood, plasminogen activator inhibitor-1 (PAI-1), which is linked with inflammation, pulmonary disease and clotting, can improve outcomes for people with COVID-19. The medicine being used in this study, TM5614, is an investigational drug, which means it is not approved by the U.S. Food and Drug Administration (FDA).
    Shah, Sanjiv JShah, Sanjiv J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04634799 STU00213262
    More Info
    Copy
    Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device
    This study is recruiting patients with Tricuspid Regurgitation (TR), a condition in which the heart’s tricuspid valve does not close tightly which causes the…
    This study is recruiting patients with Tricuspid Regurgitation (TR), a condition in which the heart’s tricuspid valve does not close tightly which causes the blood to flow in the wrong direction during part of the cardiac cycle (heart beat). This condition increases the workload on the heart and if left untreated, it can increase the risk of worsening heart failure. The goal of this trial is to evaluate the safety and effectiveness of the Study Device with Optimal Medical Therapy (OMT) compared to OMT alone in the study of subjects with severe or greater tricuspid regurgitation.
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04482062 STU00213338
    More Info
    Copy
    iCLAS™ for Persistent Atrial Fibrillation
    This study is enrolling patients who have an irregular heartbeat(arrhythmia) and have been scheduled for an ablation (procedure that destroys small area of heart tissue that causes an arrhythmia) to treat the arrhythmia. This irregular heart rhythm is also …
    This study is enrolling patients who have an irregular heartbeat(arrhythmia) and have been scheduled for an ablation (procedure that destroys small area of heart tissue that causes an arrhythmia) to treat the arrhythmia. This irregular heart rhythm is also known as atrial fibrillation, or AF. There are several forms of AF. Persistent AF is when the irregular heart rate become continuous and lasts for at least 7-days but no more than 12 months. Once it has lasted continuously for more than one-year it is referred to as long-standing persistent AF. AF may be treated with medicines, electrical shock(cardioversion), or the ablation for which the patient has been scheduled. The purpose of this study is to demonstrate the safety and effectiveness of the Adagio Medical iCLAS System when used in the treatment of persistent atrial fibrillation. The device is a new type of ablation technology that uses very low freezing temperatures.
    Knight, Bradley PaulKnight, Bradley Paul
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04061603 STU00213038
    More Info
    Copy
    Polydiuretic Therapy for Heart Failure with Preserved Ejection Fraction in Patients with or without Diabetes Mellitus: A Proof-of-Concept Randomized Trial
    This study is enrolling patients at Northwestern Memorial Hospital with a history of heart failure with preserved ejection fraction and diabetes m…
    This study is enrolling patients at Northwestern Memorial Hospital with a history of heart failure with preserved ejection fraction and diabetes mellitus. Doctors at Northwestern University want to better understand if combining three different types of medicines at low doses into one pill can simplify and improve treatment for people who are prone to retaining fluid because of a condition called heart failure with preserved ejection fraction. Specifically, this is the most common type of heart failure and occurs with a normal ejection fraction or squeezing capacity of the heart muscle. Because patients with diabetes mellitus and heart failure with preserved ejection fraction are more likely to retain fluid, we are studying people with both of these conditions. The medicines being used in this study - bumetanide, eplerenone, and dapagliflozin- are all approved by the Food and Drug Administration (FDA) and commonly prescribed by medical providers for heart failure with preserved ejection fraction (bumetanide and eplerenone) and diabetes mellitus (dapagliflozin). In this study, they will be combined into one pill, a “Low-Dose Triple Polydiuretic Therapy” or “LDTPT” to see if LDTPT leads to reduction in NT-proBNP, a hormone which is high among persons who have heart failure with preserved ejection fraction. The (FDA) has not approved the LDTPT pill for general use and its use in this study is experimental.
    Khan, Sadiya SanaKhan, Sadiya Sana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04079634 STU00213243
    More Info
    HFpEF Diabetes
    Copy
    AN EXPLORATORY, OPEN-LABEL, PROOF-OF-CONCEPT, PHASE 2A STUDY OF MAVACAMTEN (MYK-461) IN PARTICIPANTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (HFpEF) AND CHRONIC ELEVATION OF CARDIAC TROPONIN I AND/OR NT-PROBNP
    This study is recruiting patients who have been diagnosed with Heart Failure wi…
    This study is recruiting patients who have been diagnosed with Heart Failure with Preserved Ejection Fraction. The study will test whether a drug called mavacamten can lower blood levels of cardiac troponin (a marker of heart muscle injury) and/or NT-proBNP (a marker of heart wall stress). These “biomarkers” are increased in the blood of some people with HFpEF. Additionally, the main research study will provide preliminary information regarding tolerability and safety of mavacamten treatment in HFpEF. Mavacamten is an investigational drug. This means that it has not been approved by the Food and Drug Administration (FDA) or any regulatory agency for routine clinical use, including the treatment of HFpEF.
    Patel, Ravi BPatel, Ravi B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04766892 STU00213899
    More Info
    Copy
    Medtronic Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF (PULSED AF)
    This study is recruiting patients who have been diagnosed with atrial fibrillation, also known as “AF or “Afib”. AF is an irregular heartbeat (arrhythmia), often with a very fast heart rate. AF is know…
    This study is recruiting patients who have been diagnosed with atrial fibrillation, also known as “AF or “Afib”. AF is an irregular heartbeat (arrhythmia), often with a very fast heart rate. AF is known as either paroxysmal AF (symptoms stop on their own within 7 days) or persistent AF (symptoms last longer than 7 days and the heart’s rhythm can’t regulate itself anymore). The study is recruiting patients whose doctor recommend that they have a cardiac ablation procedure to treat their AF. Patients will be treated with the PulseSelect Pulsed Field Ablation(PFA) system. The purpose of this study is to provide data demonstrating the safety and effectiveness of the PFA system for the treatment of AF. The study will also provide first in human insights into clinical safety and device function of the PFA system for pulmonary vein isolation (a type of cardiac ablation procedure which focuses on treatment where the four pulmonary veins connect to the heart) as a treatment for AF.
    Knight, Bradley PaulKnight, Bradley Paul
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04198701 STU00214407
    More Info
    Copy
    A PHASE 3, RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, MULTICENTER STUDY TO EVALUATE MAINTENANCE OF RESPONSE, SAFETY AND PATIENT REPORTED OUTCOMES IN ACROMEGALY PATIENTS TREATED WITH OCTREOTIDE CAPSULES, AND IN PATIENTS TREATED WITH STANDARD OF CARE PARENTERAL SOMATOSTATIN RECEPTOR LIGANDS WHO PREVIOUSLY TOLERATED AND DEMONSTRATED A BIOCHEMICAL CONTROL ON BOTH TREATMENTS
    Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated sustained biochemical response up to 13 months in patients with acromegaly previously managed with somatostatin analog injections (ref). The purpose of this study is to compare the efficacy safety and patient reported outcomes between oral octreotide capsules and injectable somatostatin analogs.
    Huang, WenyuHuang, Wenyu
    NCT02685709 STU00202258
    More Info
    Copy
    The effects of capsinoids on brown adipose tissue recruitment and activation in obesity
    This research study is being done to determine whether taking a dietary supplement called capsinoids, derived from sweet peppers, can activate brown fat that is already present or even generate new brown fat in in…
    This research study is being done to determine whether taking a dietary supplement called capsinoids, derived from sweet peppers, can activate brown fat that is already present or even generate new brown fat in individuals with excess weight. Previous studies have suggested that chronic consumption of capsinoids may be able to generate new brown fat in thin individuals. Capsinoids may also have a small positive effect on metabolism (increased calorie-burning) and fat loss. The knowledge gained in this study may eventually lead to more treatment options for people with excess weight.
    Male, between ages 18-50, healthy, non-smoking, overweight/obese
    Neff, Lisa MNeff, Lisa M
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03110809 STU00204058
    More Info
    Copy
    Mediators of Atherosclerosis in South Asians Living in America
    South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high rates of cardiovascular disease that is not explained by traditional cardiovascular risk factors. Though South Asians r…
    South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high rates of cardiovascular disease that is not explained by traditional cardiovascular risk factors. Though South Asians represent over one-quarter of the world's population, there are no longitudinal studies in this high-risk ethnic group. The investigators aim to establish a longitudinal study of South Asians at two United States centers to identify risk factors linked to subclinical atherosclerosis and incident cardiovascular disease. The purpose of this study is to understand the causes of heart disease and stroke in South Asians and compare these causes to those in other United States ethnic groups.
    Kandula, Namratha RKandula, Namratha R
    NCT01207167 STU00019837
    More Info
    Copy
    Low InTensity Exercise intervention in PAD: The LITE Trial.
    This study is being done to determine whether an exercise intervention that avoids continuous supervision and exercise-related pain in the legs can improve walking ability in people with lower extremity peripheral artery disease (PAD).
    Peripheral artery disease
    McDermott, Mary McGraeMcDermott, Mary McGrae
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02538900 STU00105855
    More Info
    Copy
    Telmisartan Plus Exercise to Improve Functioning in PAD
    The purpose of this study is to establish whether the angiotensin receptor blocker (ARB) telmisartan improves walking performance in people with PAD. We will also determine whether telmisartan plus supervised exercise improves walking performan…
    The purpose of this study is to establish whether the angiotensin receptor blocker (ARB) telmisartan improves walking performance in people with PAD. We will also determine whether telmisartan plus supervised exercise improves walking performance more than telmisartan alone and more than supervised treadmill exercise alone.
    We are asking you to take part in this research study because you have or may have peripheral artery disease (PAD). PAD is a condition in which cholesterol blockages in the leg arteries prevent blood from getting down to the legs and feet during exercise.
    McDermott, Mary McGraeMcDermott, Mary McGrae
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02593110 STU00200954
    More Info
    Copy
    Improving Outpatient Safety of Older Adults through Electronic Patient Portals
    The objective of this study is to assess whether providing caregivers of older adults proxy access to an electronic patient portal (MyChart) improves the outpatient medication safety and communication between caregivers an…
    The objective of this study is to assess whether providing caregivers of older adults proxy access to an electronic patient portal (MyChart) improves the outpatient medication safety and communication between caregivers and health care providers.
    Adults age 65 and older, a patient in the General Internal Medicine and Geriatrics (NMFF GIM-GER) clinics, not currently enrolled in MyChart Electronic Patient Portal, English speaking, can identify a caregiver who assists with their care (can be informal e.g. adult child, spouse, caregiver agency). Additional eligibility criteria are focused on the caregiver identified: English speaking, assist the older adult with medications and communication with the health care team, and have internet access (either phone, tablet, or laptop/computer).
    Lindquist, Lee ALindquist, Lee A
    • Map it 675 N. St. Clair St.
      Chicago, IL
    STU00201242
    More Info
    Copy
    The ENabling Reduction of low-Grade Inflammation in SEniors) Pilot Study
    The purpose of the ENRGISE Pilot Study is to look at the effect of anti-inflammatory drugs on physical functioning in older adults. This study will see if two study drugs (fish oil and losartan, a commonly used blood pressure me…
    The purpose of the ENRGISE Pilot Study is to look at the effect of anti-inflammatory drugs on physical functioning in older adults. This study will see if two study drugs (fish oil and losartan, a commonly used blood pressure medicine) have an effect on walking ability.
    Age 70 or older, slow walking speed, and high levels of markers of inflammation in your blood.
    McDermott, Mary McGraeMcDermott, Mary McGrae
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02676466 STU00201974
    More Info
    Copy
    Cocoa to Improve Walking Performance in Peripheral Artery Disease: The COCOA-PAD Study
    The purpose of this study is to determine whether drinking daily cocoa-enriched beverages improves walking performance in people with PAD. Previous studies have shown that cocoa may improve blood flow, improve card…
    The purpose of this study is to determine whether drinking daily cocoa-enriched beverages improves walking performance in people with PAD. Previous studies have shown that cocoa may improve blood flow, improve cardiovascular health, and improve muscle function and strength. Some evidence suggests that cocoa may also improve walking ability in people with PAD.
    We are asking you to take part in this research study because you are age 65 or older and you have or may have peripheral artery disease (PAD). PAD is a condition in which cholesterol blockages in the leg arteries prevent adequate blood flow to the legs and feet.
    McDermott, Mary McGraeMcDermott, Mary McGrae
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02876887 STU00202741
    More Info
    Copy
    Reducing Assessment Barriers for Patients with Low Literacy
    This study aims to learn whether routine health questionnaires are valid across groups of people who have different levels of understanding of basic health information.
    You may be eligible for this study if you are the age of 18 or older, are fluent in English and/or Spanish, have no plans to move outside of the Chicagoland area in the next 6 months, and are willing to complete questionnaires on an electronic tablet or in paper & pencil format. You will be asked to complete 3 face-to-face interviews at Northwestern in downtown Chicago and will be compensated for your time and transportation.
    Griffith, James WGriffith, James W
    NCT03584490 STU00204308
    More Info
    Copy
    NU 05H6: Acute Leukemias and Map Kinase

    Normally, white blood cells are produced in a controlled way by the bone marrow. In someone with AML or ALL, this production process is abnormal and immature cells are produced and sent into the blood stream. In this immature state, the cells affect the prod…

    Normally, white blood cells are produced in a controlled way by the bone marrow. In someone with AML or ALL, this production process is abnormal and immature cells are produced and sent into the blood stream. In this immature state, the cells affect the production of other normal cells and these cannot perform their usual functions. Therefore patients with AML or ALL are vulnerable to infection, anemia, and bleeding.

    The purpose of this study is to understand what causes the white blood cells to grow abnormally, and to determine if there are novel agents that can be used to stop this abnormal growth. In this research project, a sample of blood and bone marrow will be studied in the laboratory to learn more about the nature of the disease, and to understand what causes the defect in the growth of these cells.

    You may be eligible for this research study if you have been diagnosed with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL), which are cancers of the blood that affect white blood cells.

    Platanias, Leonidas CPlatanias, Leonidas C
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00004841
    More Info
    Copy
    NCI 02X3: SPORE in Pancreatic Cancer Tissue Core

    The purpose of this research study is to examine many aspects of gastrointestinal disease including pancreatic and colon cancer, including its genetics, its early stages, and the effects of cancer on other tissues such as muscle and adipose (fat) ti…

    The purpose of this research study is to examine many aspects of gastrointestinal disease including pancreatic and colon cancer, including its genetics, its early stages, and the effects of cancer on other tissues such as muscle and adipose (fat) tissue. Tissues from patients (with cancer as well as from those without), who are undergoing pancreatic surgery, will be used in this research.

    You may be eligible for this research study if you are visiting the high risk clinic and/or are undergoing surgery to remove a portion of your pancreas.

    Yang, Guang-YuYang, Guang-Yu
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00007180
    More Info
    Copy
    NU 04H7: Molecular Mechanisms of Disease Progression in Myeloid Malignancy

    In this research project, samples of blood and bone marrow will be studied in the laboratory to learn more about the nature of chronic myelogenous leukemia (CML) cells and how various medications and chemical agents affect …

    In this research project, samples of blood and bone marrow will be studied in the laboratory to learn more about the nature of chronic myelogenous leukemia (CML) cells and how various medications and chemical agents affect them.

    The purpose of this study is to learn about how CML leukemia cells become resistant to medications or progress to acute leukemia (blast crisis). This may prove to be helpful in the design of new more effective drugs for the treatment of CML in the future.

    You may be eligible to take part in this research study if you have been diagnosed with chronic myelogenous leukemia (CML), a chronic form of leukemia, OR if you are a normal individual without any blood disorders.

    Eklund, Elizabeth AEklund, Elizabeth A
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00039629
    More Info
    Copy
    NCI 12H13: Molecular Mechanisms of Relapse After Therapy Discontinuation in Chronic Myeloid Leukemia

    In this research study, samples of bone marrow or peripheral blood will be collected from patients with chronic myeloid leukemia (CML) to learn more about the effect of some new drugs on CML cells …

    In this research study, samples of bone marrow or peripheral blood will be collected from patients with chronic myeloid leukemia (CML) to learn more about the effect of some new drugs on CML cells in the laboratory. The purpose of this study is to understand how these new drugs stop leukemia cells from growing. This research may prove to be helpful in the design of new and more effective treatments for leukemia in the future.

    You may be eligible for this research study if you have been diagnosed with chronic myeloid leukemia, a cancer of the blood and are scheduled to have a bone marrow biopsy.

    Eklund, Elizabeth AEklund, Elizabeth A
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00074258
    More Info
    Copy
    NUDB 13C03: Northwestern Brain Tumor Institute Research Database

    The Northwestern Brain Tumor Institute (NBTI) currently uses an electronic database to collect and store information about patients who come to the NBTI for evaluations, including diagnosis, treatment, follow-up, and/or to obtain add…

    The Northwestern Brain Tumor Institute (NBTI) currently uses an electronic database to collect and store information about patients who come to the NBTI for evaluations, including diagnosis, treatment, follow-up, and/or to obtain additional opinions. This database is called the Northwestern Brain Tumor Institute Database or NBTIDB, and it was developed to replace older paper methods for collecting and storing information.

    The purpose of this study is to allow researchers involved with the NBTIDB to use data stored in it for future research studies and projects. The NBTIDB also allows researchers to track whether or not patients have agreed to allow their information to be linked to their leftover tissue samples, which are kept in the hospital’s pathology department, for future research studies.

    You may be eligible to take part in the research component of the NBTIDB if you are either a new or returning patient, over the age of 18, who is being seen by one of the clinicians at the NBTI and are or will be entered into the NBTIDB, or a patient who is not coming to the NBTI for evaluation, but would still like to participate in the NBTIDB.

    Kumthekar, Priya UKumthekar, Priya U
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00087359
    More Info
    Copy
    A Phase III Randomized Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

    This randomized phase III trial studies how well the study drug (crizotinib, also known …

    This randomized phase III trial studies how well the study drug (crizotinib, also known as XALKORI®) works, and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called ALK. Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Tumors with this mutation may respond to treatments that target the mutation, such as crizotinib. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working.

    It is not yet known if crizotinib may be an effective treatment for treating non-small cell lung cancer with an ALK mutation. The addition of crizotinib may help prevent your cancer from returning, but it could also cause side effects. This research study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the study drug should improve how long you are able to live by 2 years and 9 months (33 months total) or more compared to the usual approach.

    The study drug, crizotinib, is already FDA-approved for use in ALK-positive locally advanced or metastatic (spread to other areas of the body) non-small lung cancer. The use of crizotinib in this study is investigational (not approved by the FDA) because crizotinib will be prescribed for earlier stage disease after the cancer has been surgically removed.

    You are being asked to take part in this research study because you have ALK-positive non-small cell lung cancer, which has been removed by a surgeon. 
    Mohindra, Nisha AnjaliMohindra, Nisha Anjali
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02201992 STU00102000
    More Info
    Copy
    Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

    This research trial is trying to see if tumor genetic testing would be helpful at guiding treatment in patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying…

    This research trial is trying to see if tumor genetic testing would be helpful at guiding treatment in patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes. The purpose of the study is to examine lung cancer patients’ surgically removed tumors for certain genetic changes, and to possibly refer these patients to a treatment study with drugs that may specifically target tumors that have these genetic changes.

    Genetic testing will be done to learn if your tumor has any of these genetic changes. This test will look at the genetic material of the tumor cells. All tissues in the body are made up of cells. Those cells contain DNA, which is your unique genetic material that carries the instructions for your body’s development and function. Cancer can develop when changes in certain genes cause those cells to divide in an uncontrolled way and, sometimes, to travel to other organs.

    Another purpose of this research study is to learn more about cancer and why treatments may be more effective or even stop working with some tumors or in certain patients. After your tumor tissue is screened, if there is any tissue left, the remainder of your coded tissue samples will be sent to a National Cancer Institute (NCI)-sponsored storage facility, currently known as the Biospecimen Core Resource (BCR).

    You may be eligible for this research study if you have lung cancer that has either been removed or will be removed by a surgeon. As part of your normal treatment, you may receive chemotherapy or radiation therapy to reduce the chance of the cancer coming back.

    Mohindra, Nisha AnjaliMohindra, Nisha Anjali
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02194738 STU00200150
    More Info
    Copy
    NCI 15H01: Triad1 Regulates Myelopoiesis and Functions as a Leukemia Suppressor

    Researchers have found that about 60% of patients with acute myeloid leukemia (AML) will obtain a remission following treatment with combinations of chemotherapy drugs. However, relapse after treatment remains a proble…

    Researchers have found that about 60% of patients with acute myeloid leukemia (AML) will obtain a remission following treatment with combinations of chemotherapy drugs. However, relapse after treatment remains a problem, and can be as high as 80% in some types of AML patients. Therefore, it would be beneficial to identify specific treatment approaches for patients at a high risk for relapse. One characteristic associated with high relapse rates is an increase in proteins that are referred to as Hox proteins in the leukemia cells. Increase in Hox proteins prevents production of some other proteins, including a protein referred to as Triad1. An increase in Triad1 protein in bone marrow cells may be important to control the growth of such cells. Decreased Triad1 in leukemia cells may therefore promote their growth, but this has not been previously studied.

    The purpose of this study is to investigate if the lack of Triad1 in leukemia cells contributes to resistance of some leukemias to chemotherapy drugs. This research may prove to be helpful in the design of new and more effective treatments for leukemia in the future.

    At a time when you are having a bone marrow biopsy and aspirate performed as part of your standard medical care, about an additional 2.5 teaspoons (12.5 mL) of bone marrow will be collected for this research study.

    You may be eligible for this research study if you have been diagnosed with acute myeloid leukemia (AML), a cancer of the blood.

    Eklund, Elizabeth AEklund, Elizabeth A
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00200435
    More Info
    Copy
    NU 15B01: A Single Arm Phase II Study Evaluating the Efficacy and Safety of Durvalumab (MEDI4736) in Combination with Tremelimumab in Patients with Metastatic HER2 Negative Breast Cancer: TNBC Expansion Cohort

    The main purpose of this study is to determine the anti-tumor activity of durvalumab (ME…

    The main purpose of this study is to determine the anti-tumor activity of durvalumab (MEDI4736) in combination with tremelimumab in patients with metastatic HER2-negative breast cancer.

    Both durvalumab and tremelimumab are antibodies (proteins used by the immune system to fight infections and cancers). Durvalumab attaches to a protein in tumors called PD-L1. It may prevent cancer growth by helping certain blood cells of the immune system get rid of the tumor. Tremelimumab stimulates (wakes up) the immune system to attack the tumor by binding to a protein molecule called CTLA-4 on immune cells. Combining the actions of these drugs may result in better treatment options for patients with breast cancer.

    Both durvalumab and tremelimumab are “investigational” drugs, which means that the drugs are not approved by the Food and Drug Administration. The idea behind developing these types of experimental drugs is that stimulating the immune system could be a different way of killing cancer cells.

    We will be investigating primarily the ability of this drug combination to shrink tumors, or prevent them from growing larger. We will also investigate if this drug combination can increase survival. Finally, we will explore how these drugs affect your immune system and tumor cells by conducting tests on tumor samples before and after the first two months of treatment. This will help us learn if certain types of tumor or immune system features are associated with better responses. The information learned in this study may be helpful in the further development of durvalumab and tremelimumab for the treatment of women with advanced breast cancer.

    You may be eligible for this research study if you have metastatic breast cancer that has not responded to or stopped responding to at least one line of standard-of-care chemotherapy.

    Cristofanilli, MassimoCristofanilli, Massimo
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02536794 STU00200984
    More Info
    Copy
    NU 15N01: Head and Neck Tissue Bank

    Researchers would like to create a bio-specimen bank of tissue, blood, urine and saliva, which would then be used to study cancer and find better ways to detect, prevent, diagnose, treat and provide better care for future patients. Some of these studies may be a…

    Researchers would like to create a bio-specimen bank of tissue, blood, urine and saliva, which would then be used to study cancer and find better ways to detect, prevent, diagnose, treat and provide better care for future patients. Some of these studies may be about how genes affect the development of cancer, response or resistance to treatment as well as prognosis (course of disease and overall outcome including survival). Other studies may aim to identify measurable substances in the blood and/or urine (known as biomarkers) that can indicate early development of cancer, worsening or relapse of disease and response to treatment. Some studies may lead to new products, such as drugs or tests for detection of cancer.

    You may be eligible to take part in our head and neck specimen banking study if you have one of the following conditions:

    a) You have a tumor or an abnormal area in the head and neck area, suspicious for cancer, or pre-cancerous condition or other pathology of interest, and you’re scheduled to have biopsy and/or surgery at Northwestern Memorial Hospital.

    b) You will receive treatment and/or regular follow up for further management for your head and neck cancer or precancerous condition, or other pathology at Northwestern Memorial Hospital and/or Northwestern Medicine Developmental Therapeutics Institute (NMDTI).

    Samant, SandeepSamant, Sandeep
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00202177
    More Info
    Copy
    NU 15N02: Northwestern Head and Neck Cancer Registry

    The purpose of this registry is to collect clinical information on all consenting head and neck cancer patients seen at the Northwestern Medical Group (NMG) or Northwestern Memorial Hospital (NMH). With this information, researchers will conduct…

    The purpose of this registry is to collect clinical information on all consenting head and neck cancer patients seen at the Northwestern Medical Group (NMG) or Northwestern Memorial Hospital (NMH). With this information, researchers will conduct studies to learn more about the subtypes of head and neck cancers and determine the most effective treatments. The registry will also allow us to identify possible subjects for future studies.

    You may be eligible to take part in this research study if you are being treated or have been treated for a tumor or cancer of the head and neck.

    Samant, SandeepSamant, Sandeep
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00202162
    More Info
    Copy
    Alliance A071401: Phase II Trial Of SMO/AKT/NF2 Inhibitors in Progressive Meningiomas with SMO/AKT/NF2 Mutations

    This phase II trial studies how well two drugs, vismodegib and GSK2256098, work in treating patients with meningiomas that may have gotten bigger or grew back after treatment. Vismodegi…

    This phase II trial studies how well two drugs, vismodegib and GSK2256098, work in treating patients with meningiomas that may have gotten bigger or grew back after treatment. Vismodegib and GSK2256098 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

    The purpose of this study is to test good and bad effects of these two different drugs against meningioma tumors with altered (or mutated) genes. Altered genes can cause a tumor to grow. The study drugs, vismodegib and GSK2256098, target these genes. The study drugs could shrink the cancer, or the cancer could stay the same size or grow. They may cause side effects. Researchers hope to learn if the study drugs will shrink the cancer by at least one-half compared to its present size.

    Today, therapy for meningioma is the same for all patients, and is not based on tumor genetic testing. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in meningioma patients.

    You may be eligible for this research study if you have a meningioma which has gotten bigger or grew back after treatment.

    Kumthekar, Priya UKumthekar, Priya U
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02523014 STU00202953
    More Info
    Copy
    Phase II Multicenter Study of Natalizumab Plus Standard Steroid Treatment for High Risk Acute Graft-Versus-Host Disease

    This research trial is designed to study the safety and effectiveness of adding the drug, Natalizumab (Tysabri®) to the standard treatment (which consist in the use of steroids …

    This research trial is designed to study the safety and effectiveness of adding the drug, Natalizumab (Tysabri®) to the standard treatment (which consist in the use of steroids such as prednisone i.e., a corticosteroid), as a new treatment for acute graft versus host disease (GVHD).

    GVHD is the most common serious complication after bone marrow transplant. GVHD occurs when the donor cells (the graft) treat the recipient’s body as “foreign” and attack the cells in the recipient’s body. During this immune system response, donor cells damage body tissues, such as the skin, liver, stomach, and/or intestines. GVHD can be severe and potentially fatal to the transplant recipient. The only proven effective treatment for patients with acute GVHD is steroids. Patients who do not respond to steroid treatment are at high risk for death.

    We want to test whether we can improve steroid response and prevent death from GVHD by blocking the donor cells from getting to the intestine and causing damage.

    The study drug, Natalizumab (Tysabri®), is a drug that works by blocking the signals that cause donor cells to travel to the intestine or brain. Natalizumab is FDA-approved in adults to treat Crohn’s disease, a chronic condition where immune cells cause damage to the digestive system (such as the stomach, intestines). It is also used to treat multiple sclerosis where immune cells cause damage to the nervous system in the brain. Its intended use is for patients whose disease has not responded to the standard treatment or if they cannot tolerate the side effects from standard treatments. Natalizumab has never been used for treating GVHD. It is an experimental drug for this study, because we are investigating a new use for the drug as a GVHD treatment.

    The goal of this research is to develop safer and more effective treatments for GVHD, with the ultimate goal being safer and more effective transplant therapies for blood cancers such as leukemia, lymphoma, and multiple myeloma.

    You may be eligible for this research study if you have been diagnosed with acute graft-versus-host disease (GVHD) of the GI tract.

    Adekola, KehindeAdekola, Kehinde
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02133924 STU00203346
    More Info
    Copy
    DRUG AG-221-AML-005: A phase 1B/2 open-label, randomized study of 2 combinations of isocitrate dehydrogenase (IDH) mutant targeted therapies plus azacitidine: oral AG-120 plus subcutaneous azacitidine and oral AG-221 plus SC azacitidine in subjects with newly diagnosed acute myeloid leukemia harboring an IDH1 or an IDH2 mutation, respectively, who are not candidates to receive intensive induction chemotherapy

    The purpose of this study, which involves research, is to determine a safe and tolerable dose of the investigational combination of AG-120 plus azacitidine or AG-221 plus azacitidine (Phase 1b) as well as the effectiveness of AG-221 plus azacitidine in treating this disease, when compared to azacitidine alone (Phase 2). AG-120 is not currently approved for the treatment of any type of AML and its use in this study is investigational. Recently AG-221, also known as

    enasidenib (IDHIFA®), was approved in the United States (US) for the treatment of adult patients with relapsed or refractory AML with an Isocitrate dehydragenase 2 (IDH2) mutation as detected by an FDA-approved test. The use of enasidenib in this study is investigational. Enasidenib is not currently approved in other countries for the treatment of any type of AML. Azacitidine (Vidaza®) is approved in Canada for the treatment of AML for patients with 20 - 30% bone marrow blast and multi lineage dysplasia, according to WHO classification, who are not candidates to receive hematopoietic stem cell transplantation.

    - Adults at least 18 years of age

    - Newly diagnosed, primary (i.e., de novo) or secondary (Progression of MDS or myeloproliferative neoplasms [MPN], or therapy-related) AML according to WHO classification with at least 20% leukemic blasts in the bone marrow

    - Have an IDH1 or IDH2 gene mutation

    - Not candidates to receive intensive IC.

    Frankfurt, OlgaFrankfurt, Olga
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02677922 STU00203231
    More Info
    Copy
    NUDB 16Z01: The OncoSET Program Database and Biobank - Combining Clinical Outcomes with Next Generation Sequencing and other Advanced Molecular Testing for Genetic Aberrations in Patients with Advanced Solid Malignancies

    The purpose of the study is to gather information about your cancer and the t…

    The purpose of the study is to gather information about your cancer and the treatment you receive as a part of your routine clinical care. In this study, we are developing a research registry, which is a bank of information about many patients.

    We are interested in learning about the relationship between your cancer and the different types of tests available to identify the best treatment option for you. That is, we are interested in the tests that identify possible ‘mutations’ (e.g., changes) or ‘drivers’ within your tumor, what treatments you receive after getting these tests, and how your cancer responds to the treatments.

    The tests known as next generation sequencing or “NGS” are usually done on your cancer tissue or blood samples as a part of your routine clinical care. Your doctor can use the information to identify the best treatment option for you after discussing it with other doctors. These routine tests will be performed whether you participate in this study or not, but we want to collect the information about this process for this study.

    If you participate in this study, extra samples of your blood will be collected and stored, and your health information from your medical record and NGS lab results will be collected and stored.

    You may be eligible for this research study if you have a diagnosis of cancer and are being treated at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

    Cristofanilli, MassimoCristofanilli, Massimo
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00203944
    More Info
    Copy
    Melanoma and Skin Cancer Tissue Repository

    The purpose of this study is to allow researchers studying and treating melanoma and other cancers to have access to tissue for research purposes only. Northwestern University may use your medical record information, as well as tumor, blood, saliva, urine…

    The purpose of this study is to allow researchers studying and treating melanoma and other cancers to have access to tissue for research purposes only. Northwestern University may use your medical record information, as well as tumor, blood, saliva, urine, and fecal samples (collectively called “tissue”) for research studies to help us understand melanoma and other skin cancers. Biopsies and surgery of your cancer will not be a part of this study but will be performed as part of your standard care.

    You may be eligible to take part in the research component of the Northwestern Melanoma and Skin Cancer Tissue Repository if you are either a new or returning patient and have a skin cancer or pre-cancer lesion.

    Sosman, Jeffrey AlanSosman, Jeffrey Alan
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00204151
    More Info
    Copy
    NU 16B14: I-CURE-1: A Phase II, single arm study of Pembroluzimab combined with carboplatin in patients with circulating tumor cells (CTCs) positive Her-2 negative metastatic breast cancer (MBC)

    Previous studies have indicated that in triple negative breast cancer patients with tumor recurrence, t…

    Previous studies have indicated that in triple negative breast cancer patients with tumor recurrence, those tumors are more resistant to chemotherapy and may be associated with a weak immune system. This study is investigating the use of an immune therapy drug, pembrolizumab, that has the ability to restore the capacity of controlling and killing cancer cells of an important component of your immune system called T-cells.

    This drug has been found effective in other type of cancer and already approved by FDA for those indications, but the efficacy in breast cancer is still unknown. Pembrolizumab will be combined with chemotherapy, a drug called carboplatin, to increase the cancer cell killing. There is no control or placebo treatment in this study. Use of Pembrolizumab in this study is considered investigational, meaning that the drug is not approved for the indication under investigation.

    You may be eligible for this research study if you have advanced breast cancerthat is triple negative and you have been found to have more than 5 circulating cancer cellsdetected by the FDA-approved test, CellSearch™, in one tube of blood.
    Cristofanilli, MassimoCristofanilli, Massimo
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03213041 STU00205013
    More Info
    Copy
    DRUG CA209-914: A Phase 3 Randomized Double Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab Combination vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

    The purpose of this stu…

    The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug combination of nivolumab (also known as BMS-936558) and ipilimumab (also known as BMS-734016) in subjects with localized kidney cancer that have had their tumors completely removed but are at risk of having their cancer return.

    Nivolumab and ipilimumab are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells.

    OPDIVO® (nivolumab) is approved for the treatment of certain types of cancer, including skin, kidney, blood, and lung, in multiple countries including the United States, the European Union, and Japan. Ipilimumab (Yervoy™) is approved by the FDA, EMA and other health authorities for the treatment of metastatic melanoma. The combination of nivolumab (Opdivo™) and ipilimumab (Yervoy™) is also approved by the US FDA for the treatment of advanced kidney cancer that has spread to other parts of the body and by the US FDA and the EMA for the treatment of metastatic melanoma.

    You may be eligible for this research study if you have kidney cancer and have had your tumors completely removed but are at risk of having your cancer return.

    Sosman, Jeffrey AlanSosman, Jeffrey Alan
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03138512 STU00205491
    More Info
    Copy
    A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared with Investigator’s Choice in HLA-A*0201 Positive Patients with Previously Untreated Advanced Uveal Melanoma
    This research study is investigating a drug (that is called IMCgp100) in patients with a…
    This research study is investigating a drug (that is called IMCgp100) in patients with advanced uveal melanoma. Uveal melanoma is generally treated with either chemotherapy or drugs that work by activating the immune system, known as immunotherapies. In this research study, IMCgp100 will be compared to three representative standard treatments: dacarbazine (a chemotherapy drug), ipilimumab (an immunotherapy drug targeting a protein called CTLA-4), or pembrolizumab (an immunotherapy drug targeting a protein called PD-1). This research study is being done to assess the efficacy and safety of the IMCgp100 in patients with uveal melanoma in comparison to these standard treatments.
    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT00000418 STU00205550
    More Info
    Copy
    Palbociclib after CDK and Endocrine Therapy (PACE): A Randomized Phase II study of Fulvestrant, Palbociclib, and Avelumab for Endocrine Pre-treated ER+/HER2- Metastatic Breast Cancer

    This research study is studying three combinations of drugs as treatments for this type of cancer:

    • Ar…

    This research study is studying three combinations of drugs as treatments for this type of cancer:

    • Arm A: fulvestrant
    • Arm B: fulvestrant with palbociclib
    • Arm C: fulvestrant with palbociclib and avelumab

    This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. “Investigational” means that the intervention is being studied and the researchers are trying to find out more about it— for example, the side effects it may cause, and the activity of a drug, or combination of drugs, against a cancer.

    In this research study, we are evaluating the activity of fulvestrant alone, fulvestrant and palbociclib, or fulvestrant, palbociclib, and avelumab in participants with metastatic hormone receptor positive breast cancer that has previously stopped responding to prior palbociclib therapy, or another medication in the class of therapy called CDK 4/6 inhibitors.

    You may be eligible for this research study if you have breast cancer that has spread to other parts of your body (metastatic cancer) and your cancer is hormone receptor positive. This study is designed for patients who have previously had exposure to the medication palbociclib, or another medication in the class of therapy called CDK 4/6 inhibitors.

    Shah, Ami NShah, Ami N
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03147287 STU00207256
    More Info
    Copy
    A Phase Ib/ II Study of Sorafenib and Pembrolizumab in Advanced Hepatocellular Cancer (HCC)

    The standard therapy for advanced hepatocellular carcinoma (HCC) that cannot be treated with surgery is sorafenib (Nexavar®). Sorafenib works by interfering with signaling pathways in the body that cause n…

    The standard therapy for advanced hepatocellular carcinoma (HCC) that cannot be treated with surgery is sorafenib (Nexavar®). Sorafenib works by interfering with signaling pathways in the body that cause normal and cancerous cells to grow and multiply. While sorafenib is an effective drug for treating HCC, there is evidence suggesting that combining sorafenib therapy with pembrolizumab may be more effective than sorafenib by itself.

    Pembrolizumab, which is approved in the USA and some other countries, is available by prescription to treat several different cancers, but is not approved to treat HCC. Pembrolizumab works by helping the immune system to fight cancer. However, pembrolizumab can also cause the immune system to attack normal organs and tissues in the body and can affect the way they work, which can result in side effects that may become serious or life-threatening, and in some cases, may lead to death.

    The purpose of this study is to test the safety of giving pembrolizumab in combination with sorafenib, and to look at the effect that this combination has on HCC and how it responds to this treatment.

    You may be eligible for this research study if you have hepatocellular carcinoma (HCC), which is the most common type of liver cancer and usually occurs with chronic liver disease.

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03211416 STU00207399
    More Info
    Copy
    Phase I/II Study to Evaluate the Safety and Efficacy of Nivolumab in Combination with R-CHOP in a Cohort of Patients with DLBCL/tFL/ high grade B-NHL

    The purpose of this research study is to evaluate a new drug, nivolumab, given in combination with standard chemotherapy, for the treatment of diffu…

    The purpose of this research study is to evaluate a new drug, nivolumab, given in combination with standard chemotherapy, for the treatment of diffuse large B-cell lymphoma (DLBCL).

    The standard chemotherapy regimen for DLBCL and many other aggressive B-cell non-Hodgkin lymphomas is called “R-CHOP” and includes the drugs: Rituximab (R), Cyclophosphamide (C), Doxorubicin (H), Vincristine (O) and Prednisone (P). The new drug, nivolumab, works by targeting the immune system and increasing the effect of immune cells against the cancer cells.

    The purpose of the study is to determine if the combination of nivolumab with R-CHOP is safe and will not cause significant or dangerous side effects. We also want to see how well the combination works in controlling the cancer growth, and whether or not it improves symptoms and quality of life in those who participate in the study.

    Nivolumab is investigational, which means that it has not been approved by the FDA for the treatment of this kind of cancer. However, it has been studied and approved by the FDA for other types of cancer.

      You may be eligible for this research study if you have been diagnosed with aggressive diffuse large B-cell lymphoma (DLBCL) or another form of aggressive B-cell non-Hodgkin lymphoma, and you have not been treated for this type of cancer.

      Karmali, ReemKarmali, Reem
      • Map it 201 East Huron Street Suite 12-160​
        Chicago, IL
      NCT03704714 STU00207793
      More Info
      Copy
      (xIRB NCI CIRB) ALLIANCE A041501: A PHASE III TRIAL TO EVALUATE THE EFFICACY OF THE ADDITION OF INOTUZUMAB OZOGAMICIN (A CONJUGATED ANTI-CD22 MONOCLONAL ANTIBODY) TO FRONTLINE THERAPY IN YOUNG ADULTS (AGES 18-39 YEARS) WITH NEWLY DIAGNOSED PRECURSOR B-CELL ALL
      The first purpose of this study is to te…
      The first purpose of this study is to test the safety of adding a new drug called inotuzumab to the usual chemotherapy drugs. The second purpose of this study is to compare any good and bad effects of using inotuzumab along with the usual chemotherapy treatment to using the usual treatment alone. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. Inotuzumab is investigational and is not FDA-approved.
      You may be able to take part in this study if you have acute lymphoblastic leukemia (ALL) and are 18 to 39 years old.
      Dinner, Shira NaomiDinner, Shira Naomi
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03150693 STU00208162
      More Info
      Copy
      An Open-Label, Expanded Access Program of Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant

      This research study is a type of treatment program called an Expanded Access Program sponsored by Incyte Corporation. The purpose of the Prog…

      This research study is a type of treatment program called an Expanded Access Program sponsored by Incyte Corporation. The purpose of the Program is to give access to the investigational drug, ruxolitinib, to graft-versus-host disease (GVHD) patients in the United States who are not eligible or able to participate in clinical trials.

      A second objective is to monitor the safety of ruxolitinib in GVHD patients.

      Ruxolitinib is an investigational drug that is being studied for use in the treatment of GVHD. “Investigational” means that ruxolitinib has not been approved by the FDA (Food and Drug Administration) for use as a prescription or over-the-counter medication.

      You may be eligible for this research study if you have acute or chronic graft-versus-host disease (GVHD) but are not eligible or able to obtain ruxolitinib by participating in clinical trials.

      Frankfurt, OlgaFrankfurt, Olga
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03147742 STU00208471
      More Info
      Copy
      (xIRB NCI CIRB) CCTG MA.39: TAILOR RT: A Randomized Trial Of Regional Radiotherapy In Biomarker Low Risk Node Positive Breast Cancer
      In addition to endocrine therapy and possibly chemotherapy, many women with node positive breast cancer will also receive radiotherapy to the whole breast/chest area an…
      In addition to endocrine therapy and possibly chemotherapy, many women with node positive breast cancer will also receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called regional radiotherapy). Because no one really knows whether patients with low risk breast cancer need to receive regional radiotherapy, it is possible that some women who get it may not actually need it. These women may be exposed to the side effects of their treatment without benefit. The purpose of this study is to learn if not giving regional radiotherapy is just as good as using regional radiotherapy by comparing any good and bad effects of both approaches. The study has two randomly assigned study groups; Group 1 will receive regional radiotherapy and Group 2 will not. 
      Patients who are of 40 years of age or older may be able to take part in this study if they have newly diagnosed breast cancer that has been treated with breast-conserving surgery or mastectomy and has not spread to other parts of the body.
      Donnelly, Eric DonaldDonnelly, Eric Donald
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03488693 STU00208897
      More Info
      Copy
      DRUG CD07_TNBC: A Phase Ib/II Study of Leronlimab (PRO 140) Combined with Carboplatin in Patients with CCR5+ Metastatic Triple-Negative Breast Cancer (mTNBC)
      The purpose of this study to find out if the study drug, leronlimab (PRO 140), when given incombination with another chemotherapy drug, carbopl…
      The purpose of this study to find out if the study drug, leronlimab (PRO 140), when given incombination with another chemotherapy drug, carboplatin, is safe and effective for the treatmentof patients with metastatic Triple Negative Breast Cancer (mTNBC).

      You may be eligible to take part in this research study if you have Triple Negative Breast Cancer that has come back, i.e. spread to other areas of your body (metastatic), after you have previously received chemotherapies at the time when your cancer was first detected.

      Cristofanilli, MassimoCristofanilli, Massimo
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03838367 STU00209594
      More Info
      Copy
      (xIRB NCI CIRB) ECOG-ACRIN 9152: A Phase Ib/II Study of Venetoclax (ABT-199) in Combination with Liposomal Vincristine in Patients with Relapsed or Refractory T-cell or Bcell Acute Lymphoblastic Leukemia
      This study is being done to determine what effects (good and bad) the therapy venetoclax has on y…
      This study is being done to determine what effects (good and bad) the therapy venetoclax has on your type of cancer (acute lymphoblastic leukemia, also known as ALL). This investigational therapy will be added to what is a standard, liposomal vincristine, to treat relapsed acute lymphoblastic leukemia.
      You may be eligible for this research study if you have acute lymphoblastic leukemia, which has grown after your first treatment regimen or has recurred.
      Dinner, Shira NaomiDinner, Shira Naomi
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03504644 STU00210605
      More Info
      Copy
      DRUG DCC-2036-01-003: An Open-Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination with Paclitaxel to Assess Safety, Tolerability, and Pharmacokinetics in Patients with Advanced or Metastatic Solid Tumors
      This study will evaluate the safety and tolerability of rebastinib when …
      This study will evaluate the safety and tolerability of rebastinib when taken in combination with the anti-cancer chemotherapy paclitaxel (also known as Taxol or Onxal). 
      You may be eligible to take part in this research study if you have been diagnosed withtriple-negative breast cancer, inflammatory breast cancer, ovarian cancer or endometrial cancer.
      Cristofanilli, MassimoCristofanilli, Massimo
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03601897 STU00210178
      More Info
      Copy
      DRUG AL3818-US-004: A Phase III Study of AL3818 (Catequentinib, Anlotinib) Hydrochloride Monotherapy in Subjects with Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma

      If you have ASPS, the main purpose of the study is to learn if you respond to treatment with …

      If you have ASPS, the main purpose of the study is to learn if you respond to treatment with a drug called AL3818. If you have either LMS or SS, the main purpose is to learn if AL3818 delays the time until your cancer worsens when compared to another drug called dacarbazine.

      You may be eligible for this research study if you have a soft tissue sarcoma (STS) - specifically alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), or synovial sarcoma (SS) - and you either need new treatment or your prior treatments have not been effective.
      Pollack, Seth MichaelsPollack, Seth Michaels
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03016819 STU00210420
      More Info
      RTK inhibitor
      Copy
      (xIRB) NCI CIRB: ECOG-ACRIN Z171: Prospective validation trial of taxane therapy (docetaxel or weekly paclitaxel) and risk of chemotherapy-induced peripheral neuropathy in African American women

      This study isbeing done to determine which routine course of treatment (docetaxel orpaclitaxel) will re…

      This study isbeing done to determine which routine course of treatment (docetaxel orpaclitaxel) will result in less nerve damage (known as peripheral neuropathy)in African-American women.

      You may beeligible to participate in this study if you are an adult with breast cancerand if you self-identify as black, African American, or of African descent.

      Shah, Ami NShah, Ami N
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04001829 STU00210984
      More Info
      Copy
      (xIRB Sterling) DRUG 68284528MMY2003: A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma (CARTITUDE-2)
      The purpose of this study is to see if JNJ-68284528 is safe and useful for treating p…
      The purpose of this study is to see if JNJ-68284528 is safe and useful for treating patients with relapsed or refractory multiple myeloma. In this type of treatment, your white blood cells (which are a part of the immune system) will be genetically modified to become JNJ-68284528 and used to treat your multiple myeloma.

      Some of the eligibility criteria include:

      • Participants must have a diagnosis of multiple myeloma
      • Participants must be 18 or older.
      Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
      Singhal, SeemaSinghal, Seema
      • Map it 251 E. Huron St.
        Chicago, IL
      NCT04133636 STU00210994
      More Info
      Copy
      (xIRB) NCI CIRB Alliance A021703: Randomized Double-blind Phase III Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer (SOLARIS)

      Participants with colorectal cancer will beinvited to participant in this study. The purpose of this study is to comp…

      Participants with colorectal cancer will beinvited to participant in this study. The purpose of this study is to comparethe usual treatment (usual chemotherapy plus bevacizumab) plus high-dosevitamin D3 to using the usual treatment plus regular-dose vitamin D3. Thisstudy will help the study doctors find out if this different approach isbetter, the same, or worse than the usual approach. To decide if it is better,the study doctors will be looking to see if the addition of high-dose vitaminD3 to usual approach can shrink or stabilize tumors for a longer period of timethan regular-dose vitamin D3 and usual approach.

      This study has two groups:

      Group 1: Participants in this group will getthe usual drug regimen used to treat this type of cancer, either FOLFOX plusbevacizumab or FOLFIRI plus bevacizumab, plus a study drug called high-dosevitamin D3.

      Group 2: Participants in this group you willget the usual drug regimen used to treat this type of cancer, either FOLFOXplus bevacizumab or FOLFIRI plus bevacizumab, plus a study drug calledregular-dose vitamin D3.

      Participants who are at least 18 years of age or older who have advanced colorectal cancer. 
      Kircher, Sheetal MehtaKircher, Sheetal Mehta
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04094688 STU00211478
      More Info
      Copy
      DRUG KO-MEN-001: A Phase 1/2A First in Human Study of the Menin-MLL(KMT2A) Inhibitor KO-539 in Patients with Relapsed or Refractory Acute Myeloid Leukemia
      The main purpose of this study is to determine the tolerability and the potential safety of a new drug called KO-539 in treating your cancer. …
      The main purpose of this study is to determine the tolerability and the potential safety of a new drug called KO-539 in treating your cancer. 
      You may be eligible to take part in this research study if you have a type of cancer called acute myeloid leukemia (AML) that has not responded to standard therapy.
      Altman, Jessica KAltman, Jessica K
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04067336 STU00211062
      More Info
      Copy
      (xIRB) DRUG AG881-C-004: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of AG-881 in Subjects with Residual or Recurrent Grade 2 Glioma with an IDH1 or IDH2 Mutation
      The main purpose of this research study is to investigate the safety and efficacy (usefulness) of AG-881 as…
      The main purpose of this research study is to investigate the safety and efficacy (usefulness) of AG-881 as compared to placebo (a medically inactive substance) in subjects with residual or recurrent Grade 2 glioma that have an IDH1 or IDH2 mutation.

      Some of the eligibility criteria include:

      • Participants must be 18 or older.
      • Be able to understand and willing to sign informed consent and willing to comply with scheduled visits, treatment plans, procedures, and laboratory tests, including serial peripheral blood sampling and urine sampling, during the study.
      Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
      Kumthekar, Priya UKumthekar, Priya U
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04164901 STU00211620
      More Info
      Copy
      (xirb) DRUG RMC-4630-02 A Phase 1b/2, Open Label, Multicenter, Dose Escalation and Dose-Expansion Study of the Combination of RMC 4630 with Cobimetinib in Adult Participants with Relapsed/Refractory Solid Tumors and a Phase 1b Study of RMC-4630 with Osimertinib in Participants with Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
      This study contains two different study arms. The purpose of one arm (called cobimetinib arm) is to test a new drug called RMC-4630 in combination with cobimetinib (COTELLIC®). The purpose of the second arm (called osimertinib arm) is to test a new drug called RMC-4630 in combination with osimertinib (TAGRISSO®).

      The study will test different doses of RMC-4630 in combination with cobimetinib and RMC-4630 in combination with osimertinib to determine which combination of doses is safe and tolerated. This study will also test how your body processes RMC-4630 and cobimetinib or RMC-4630 and osimertinib when given together.

      You may be eligible to participate in this study if your cancer has returned after treatment or did not respond to treatment. 
      Chae, Young KwangChae, Young Kwang
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03989115 STU00211907
      More Info
      Copy
      (xirb) Drug EZH-1201: A Phase I, Open-label Multi-dose Pharmacokinetic and Safety Study of Oral Tazemetostat in Subjects with Moderate and Severe Hepatic Impairment with Advanced Malignancies
      Tazemetostat (EPZ-6438) is an experimental study drug that has not yet been approved. This study intends to f…
      Tazemetostat (EPZ-6438) is an experimental study drug that has not yet been approved. This study intends to find out what effects, good and/or bad, it has on you and in the treatment of your cancer. 
      You may be eligible to take part in this study if you have advanced cancer that has spread to different parts of your body after receiving certain types of therapy. 
      Mahalingam, DevalingamMahalingam, Devalingam
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04241835 STU00212081
      More Info
      EPZ-6438
      Copy
      (xIRB) DRUG CO-338-100: LODESTAR: A Phase 2 MuLticenter, Open-label Study of Rucaparib as Treatment for SoliD Tumors Associated with DEleteriouS MuTations in Homologous RecombinAtion Repair Genes
      The goal of this study is to find biomarkers in subjects with different types of cancers with specific HR…
      The goal of this study is to find biomarkers in subjects with different types of cancers with specific HRR gene mutations to help doctors decide if rucaparib is a good study treatment option. One of the main goals of biomarker research is to develop a diagnostic test that might help show which subjects are most likely to benefit from study treatment with rucaparib.

      - Aged at least 18 years old

      - Have an unresectable, locally advanced (primary or recurrent) or metastatic solid tumor and have relapsed/progressive disease confirmed by radiologic assessment

      - Have one of several specific mutations that is confirmed by lab testing

      - Have received at least 1 line of available therapy

      Kalyan, AparnaKalyan, Aparna
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04171700 STU00212482
      More Info
      Copy
      (xIRB) DRUG 5F9009: ENHANCE: A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination with Azacitidine versus Azacitidine Plus Placebo in Treatment-naïve Patients with Higher Risk Myelodysplastic Syndrome

      The purpose of this study is to compare the effects, both good and …

      The purpose of this study is to compare the effects, both good and bad, of magrolimab in combination with azacitidine, to those of azacitidine in combination with placebo, to find out which is better for treating patients with Myelodysplastic Syndrome (MDS).

      Other purposes of this study include determining the quantity of magrolimab in the blood, aspects of your disease management (e.g. if you can have less frequent blood transfusions), your quality of life and the side effects magrolimab has on the body.

      This is a randomized double-blind study. “Randomized” means that you will be randomly assigned (like the flip of a coin) to receive either magrolimab in combination with azacitidine, or placebo in combination with azacitidine. There is an equal chance (1 in 2, or 50%) that you will be assigned to the magrolimab with azacitidine treatment or to the placebo with azacitidine treatment. Using a placebo is important so that the effects of magrolimab can be well understood and to determine whether magrolimab in combination with azacitidine is better than receiving azacitidine alone.

      All prospective patients will undergo screening tests to determine if they are eligible to take part in the study.

      If you qualify, each day for the first 7 days of each cycle, you will receive a dose of azacitidine.

      You will receive azacitidine by intravenous (IV) infusion, given directly into the blood by inserting a needle into a vein in your arm; or by or subcutaneous (SC) injection, given under the skin. If you are receiving magrolimab or placebo on the same day, you must will wait at least an hour after the azacitidine to start the magrolimab or placebo infusion that day.

      On Days 1, 4, 8, 11, 15, and 22 of Cycle 1 and then weekly (Day 1, 8, 15, 22) for Cycle 2, you will receive a dose of magrolimab or placebo. The dose of magrolimab will be increased during the first weeks of the study until reaching a final dose of 30 mg/kg from Cycle 2 onwards. You will receive magrolimab or placebo by infusion (IV injection), given directly into the blood, by inserting a needle into a vein in your arm and allowing magrolimab or placebo to slowly enter your body. During the first two weeks of magrolimab or placebo administration, you will receive pre-medication with acetaminophen (Tylenol ®) and diphenhydramine (Benadryl ®). For the first 4 weeks of treatment, the dose of magrolimab or placebo will be administered over approximately 3 hours. After the 4th week, the doses of magrolimab or placebo will be administered over approximately 2 hours. If you have a central line port, the port may be used for this infusion. You will be monitored for 1 hour post-infusion for the first four weeks.

      Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

      Some of the eligibility criteria include:

      •Age of at least 18 years

      •Diagnosis of Myelodysplastic Syndrome (MDS)

      Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

      Additional information can be found by visiting the NIH website:

      https://clinicaltrials.gov/ct2/show/NCT04313881

      Dinner, Shira NaomiDinner, Shira Naomi
      • Map it 251 E. Huron St.
        Chicago, IL
      NCT04313881 STU00212732
      More Info
      Copy
      (xIRB) NCI CIRB ECOG-ACRIN 5181: Randomized Phase III Trial of MEDI4736 (durvalumab) as Concurrent and Consolidative Therapy or Consolidative Therapy Alone for Unresectable Stage 3 NSCLC

      The purpose of this study is to compare the usual approach of chemo/radiationfollowed by one year of MEDI4736 (…

      The purpose of this study is to compare the usual approach of chemo/radiationfollowed by one year of MEDI4736 (durvalumab) to chemo/radiation with MEDI4736(durvalumab) followed by one year of MEDI4736 (durvalumab) for participants whohave locally advanced non-small cell lung cancer that cannot be removed. This study will help researchers find out ifthis different approach is better, the same, or worse than the usual approach.To decide if it is better, the study doctors will be looking to see if thestudy drug extends the life of patients and/or prevents the tumor from comingback as compared to the usual approach.

      This study has two groups:

      • Group 1 (Arm A,Arm C)

      Participants in this group will get the study drug, MEDI4736(durvalumab), once every other week during the first, third, and fifth weeks ofchemo/radiation (Arm A). One year of MEDI4736 (durvalumab) (Arm C)

      • Group 2 (Arm B,Arm C)

      Participants in this group will receive only standardchemo/radiation (Arm B). One year of MEDI4736 (durvalumab) (Arm C).

      For this study, all patients, including those who discontinueprotocol therapy early, will be followed for response until progression, evenif non-protocol therapy is initiated and after consolidation has ended, and forsurvival for 10 years from the date of registration. During this follow-upperiod, participants will have clinic visits every 3 months until the end oftheir 2nd year on the study, and then every 6 months until the end of their10th year on study.

      Participants 18 years of age or older who have locally advanced non-small cell lung cancer that cannot be removed.
      Mohindra, Nisha AnjaliMohindra, Nisha Anjali
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04092283 STU00212961
      More Info
      Copy
      NCICOVID: NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study

      Thepurpose of this study is to collect blood samples, medical information, andcopies of medical images from patients who are being treated for cancer and haveCOVID-19. Researchers will use thesesampl…

      Thepurpose of this study is to collect blood samples, medical information, andcopies of medical images from patients who are being treated for cancer and haveCOVID-19. Researchers will use thesesamples, information, and images to answer questions about how cancer affectsCOVID-19 and how COVID-19 affects cancer treatment outcomes.

      Oneof the future research studies we expect to do with these blood samples isgenomic or genetic sequencing. Thesesequencing studies will be done to try to find genetic traits that might mean aperson with cancer has a better or worse outcome when they are infected withCOVID-19. They will also look at whetherthere are genetic traits that might mean being infected with COVID-19 affectscancer treatment outcomes.

      Participantswho have already tested positive or if a coronavirus test result comes back andis positive, researchers will collect blood samples, COVID-19 and cancertreatment and outcome information, and copies of medical images such ascomputerized tomography (CT) scans to use for future research on COVID-19 incancer patients. For participants who are waiting for the results of theircoronavirus test, researchers will collect information about your medicalhistory and cancer history, but will not collect any blood samples or medicalimages yet. If the test result comesback and is negative, you will stop being in the study and no furtherinformation will be collected, but we will do research using the information wehave already collected.

      Participants 18 years or older who are being treated for cancer and have COVID-19 will be enrolled.
      Wehbe, FirasWehbe, Firas
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04387656 STU00213072
      More Info
      COVID-19
      Copy
      (xIRB) NCI CIRB ECOG-ACRIN 2185: Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs

      The purpose of this study is tocompare the two approaches for monitoring pancreatic cysts. The doctors want tosee if less frequent monitoring is better or worse than more frequentmonitoring for …

      The purpose of this study is tocompare the two approaches for monitoring pancreatic cysts. The doctors want tosee if less frequent monitoring is better or worse than more frequentmonitoring for patients with pancreatic cysts.

      This study has 2 study groups:

      Group 1

      Participants in this group willget less frequent monitoring. Participants will receive an MRI or CT imagingscan at the beginning of the study and repeat the scan 1 year after joining thestudy. If the scans show normal results, scans will be repeated every 2 years.If the scans show abnormal results, participants will receive an endoscopicultrasound.

      Group 2

      Participants in this group willget more frequent monitoring. Participants will receive an MRI or CT imagingscan at the beginning of the study. . The frequency of repeat imaging couldrange from every 6 months to every 2 years, based on the size of theparticipant's pancreatic cyst.

      Participants will be enrolled forup to five years.

      Participants between the ages of 50and 75 who have pancreatic cysts will be enrolled into this study.

      Yang, Anthony DYang, Anthony D
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04239573 STU00213102
      More Info
      Copy
      (xIRB) NCI CIRB ECOG-ACRIN 1183: FDG PET to Assess Therapeutic Response in Patients with Bone-Dominant Metastatic Breast Cancer, FEATURE

      The purpose of this study is to test if animaging test, FDG-PET/CT is useful for detecting changes in breast cancer bonemetastases with treatment. The study doct…

      The purpose of this study is to test if animaging test, FDG-PET/CT is useful for detecting changes in breast cancer bonemetastases with treatment. The study doctors want to see if FDG-PET/CT scansare better than the other imaging options (ie, bone scan, CT, and MRI) mostoften used to monitor breast cancer bone metastases over time.

      All participants will complete two FDG-PET/CTscans. One scan will take place prior to starting initial or new treatment formetastatic breast cancer. The second scan will take place approximately 12weeks after starting treatment. After the 12 week FDG-PET/CT scan, participantswill continue to be monitored with exams, labs and imaging which may includestandard of care CT, bone scan, MRI or FDG-PET/CT. These evaluations will occurevery 3 months for 1 year and then every 6 months for as long as needed basedon the response of the breast cancer to treatment.

      Participants who are 18 years of age or olderwho have metastatic breast cancer involving bones in your skeleton.

      Shah, Ami NShah, Ami N
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04316117 STU00213217
      More Info
      Copy
      (xirb) DRUG 7465-CL-202 : An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects with Previously Treated Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

      The goal of this study is to find out if enfortumab vedotin is effective and safe as a …

      The goal of this study is to find out if enfortumab vedotin is effective and safe as a treatment for people with breast, lung, head and neck, gastric, gastroesophageal junction, or esophageal cancer. The study will look at how enfortumab vedotin acts in the body. Enfortumab vedotin is expected to work by attacking cells that have a protein called Nectin-4. Some, but not all, of the risks and benefits of the drug are known.

      You may be eligible to participate in this study if you have breast, lung, head and neck, gastric, gastroesophageal junction, or esophageal cancer; your cancer has spread to nearby tissues (locally advanced) or other areas of the body (metastatic); and you have also received previous anticancer therapy.

      Participants may withdraw at any time.

      Mulcahy, Mary FrancesMulcahy, Mary Frances
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04225117 STU00213246
      More Info
      Nectin-4
      Copy
      (xIRB) NCI CIRB ECOG-ACRIN 2186: A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients with Treatment Naïve Metastatic Pancreatic Cancer (GIANT)

      The purpose of this study is to determine whether Gemcitabi…

      The purpose of this study is to determine whether Gemcitabine and Nab-paclitaxel or 5-Fluorouracil,

      Leucovorin, and Liposomal Irinotecan are more effective treatments for vulnerable patients

      over the age of 70 with newly diagnosed metastatic pancreatic cancer (mPCA).

      These drugs are already approved by the FDA for use in pancreatic cancer. But, it is unknown

      which combination is the most effective for vulnerable mPCA patients over the age of 70.

      This study will help the study doctors find out which approach is better at prolonging the life

      of patients over 70 with mPCA. To determine this, the study doctors will be looking to see which

      of the two approaches shows better results.

      Participants who participate will be randomized to either get Gemcitabine and Nab-paclitaxel

      every other week or 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan every other week.

      This study has 2 study groups.

      Group 1 (Arm A)

      Participants in this group will get the combination treatment of Gemcitabine and Nab-paclitaxel.

      Group 2 (Arm B)

      Participants in this group will get the combination treatment of 5-Fluorouracil, Leucovorin,

      and Liposomal Irinotecan.

      Your doctor will continue to follow your condition for up to 2 years after you start the study,

      and watch you for side effects and monitor your cancer.

      Vulnerable patients over the age of 70 with newly diagnosed metastaticpancreatic cancer (mPCA).
      Kalyan, AparnaKalyan, Aparna
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04233866 STU00213326
      More Info
      mPCA
      Copy
      Prospective Molecular Profiling To Guide Therapeutic Decision-making in Patients with Advanced Hepatocellular Cancer (HCC): An Insight to Next Generation Sequencing-Matched Systemic Therapy in Liver Cancer (PROTOLIGHT STUDY)

      Hepatocellular carcinoma (HCC) is the most common form of liver cancer, m…

      Hepatocellular carcinoma (HCC) is the most common form of liver cancer, making up approximately 90% of all liver cancers. It is the fourth largest contributor to cancer-related deaths worldwide. HCC is considered to be a complex tumor. Despite recent drug approvals for HCC, it has become clear that only some populations of patients benefit from certain drugs. This leads researchers to suspect that treatment for HCC would be more effective if we could match specific characteristics of a patient’s tumor with a drug that targets them best. Genomic analysis using an FDA-approved method called Next Generation Sequencing (NGS) could be used to potentially help physicians make such treatment decisions. The purpose of this study is to see how long patients will benefit if genomic analysis of their tumors is used to recommend more targeted treatments for HCC from a number of FDA-approved drugs.

      Eligible participants are at least 18 years of age and have advanced hepatocellular cancer (HCC) or recurrent HCC for which they have not yet received systemic therapy for, and are are not candidates for resection, transplant or liver-directed therapies.
      Mahalingam, DevalingamMahalingam, Devalingam
      • Map it 201 E. Huron St.
        Chicago, IL
      STU00212975
      More Info
      Copy
      (xIRB) DRUG 1951-CL-0101: A Phase 1b Study of ASP1951, a GITR Agonistic Antibody, as a Single Agent and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

      The purpose of this study is to determine at what dose the study drug (ASP1951 alone or ASP1951 plus pembrolizumab) is sa…

      The purpose of this study is to determine at what dose the study drug (ASP1951 alone or ASP1951 plus pembrolizumab) is safe and tolerated and how it is processed in the blood of subjects with tumors that cannot be removed (unresectable) or has spread (metastasized) to a different part of the body. During this period, the study drug will be continuously assessed to determine if it is safe and tolerated by subjects taking it.

      This is an open-label study, which means both you and your study doctor will know what study drug you will be receiving. Many dose levels will be tested in the study. It is not known which dose, if any, will work the best. Y Your study doctor will inform you which study drug dose you will be assigned to at the time of screening and if you qualify to enroll in the study.

      The study consists of up to 3 periods: Screening; Study Treatment; Follow-up; and if you qualify and are willing to continue, a Re-treatment period.

      The study drug will be given directly into your veins through an intravenous (IV) infusion.

      Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

      Some of the eligibility criteria include:

      •Age of at least 18 years

      •Diagnosis of a tumor that cannot be removed through surgery (unresectable) or may have spread (metastasized) to other parts of your body.

      Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

      Mulcahy, Mary FrancesMulcahy, Mary Frances
      • Map it 251 E. Huron St.
        Chicago, IL
      NCT03799003 STU00213423
      More Info
      Copy
      (xIRB) DRUG XPORT-GBM-029: A Phase 1/2 Study of Selinexor in Combination with Standard of Care (SoC) Therapy for Newly Diagnosed or Recurrent Glioblastoma
      The purpose of this research study is to see if the combination of approved Glioblastoma (GBM) medications, together with the study drug, selinexo…
      The purpose of this research study is to see if the combination of approved Glioblastoma (GBM) medications, together with the study drug, selinexor (also known as XPOVIO), has any effects on your cancer. Selinexor is approved by the U.S. Food and Drug Administration (FDA) for the use in certain patients with multiple myeloma but is considered to be investigational for the use in GBM. Investigational means that it has not been approved by the FDA, Health Canada, or any other regulatory agencies for the treatment of GBM.

      This is an open-label study, which means that both you and your study doctor will know how much selinexor and the names of the other medications you are taking. This study includes the following different treatment combination arms:

      •Arm A – Selinexor plus radiation treatment in patients with newly diagnosed, unmethylated GBM

      •Arm B – Selinexor plus temozolomide (TMZ) and radiation treatment in patients with newly diagnosed, methylated GBM

      •Arm C – Selinexor plus lomustine in patients with recurrent GBM

      All prospective patients will undergo screening tests to determine if they are eligible to take part in the study. Your study doctor will decide which combination is right for you, based on what therapies are available in your location and based on your diagnosis and treatments you have had in the past.

      There are two parts of this study. The first part is a “dose-escalation phase,” where the purpose is to find the best dose and the best treatment schedule of the above combinations, based on how well the medications work together and how safe they are when they are given together. The second part, the “dose-expansion phase,” will be used to see how well the best dose and treatment schedule from part 1 works when given to a larger group of patients.

      If you are assigned to Arm A or B for the dose-expansion phase and are assigned to the control treatment, you will receive a maximum of 7 cycles of treatment which is consistent with what the FDA or other regulatory agency has approved. If you are a part of the dose-escalation phase of Arm A or B, the dose-expansion phase for Arm A or B and are assigned to the treatment arm, or if you are assigned to Arm C, you can continue to receive study treatment as long as your doctor thinks you are benefitting from therapy, until the study ends, your disease progresses, you have side effects that makes you want to not continue, you decide to withdraw from the study, your study doctor decides you should not continue, or you become pregnant (if applicable).

      For each visit, your study doctor will review your data and perform some tests to see if it is appropriate for you to continue in this study. Selinexor, the study drug, comes in tablet form and should be swallowed whole with about one-half of a cup of water. Selinexor can be taken with or without food.

      Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

      Some of the eligibility criteria include:

      •Age of at least 18 years

      •Newly Diagnosed or Recurrent Glioblastoma

      Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

      Kumthekar, Priya UKumthekar, Priya U
      • Map it 251 E. Huron St.
        Chicago, IL
      NCT04421378 STU00213433
      More Info
      Copy
      (xIRB) DRUG 209627: A Phase I Study to Evaluate the Pharmacokinetics and Safety of Belantamab Mafodotin Monotherapy in Participants with Relapsed or Refractory Multiple Myeloma Who Have Normal and Varying Degrees of Impaired Hepatic Function (DREAMM 13)

      The purpose of this study is to find out the…

      The purpose of this study is to find out the relationship between liver function and safety and pharmacokinetics of study drug. Pharmacokinetics means study of the movement of drug through the body, and this study will be looking to see if liver disease affects that movement.

      This is a study in people with relapsed (returning) and/or refractory (not responding to treatment) multiple myeloma (RRMM) with various grades of impaired liver function to test how the study drug belantamab mafodotin (a drug being tested to treat people with RRMM) behaves in people with liver disease. There are 2-parts to the study. Participants with RRMM from 3 groups based on how well your liver functions can take part in the study.

      Part Group Hepatic function group Number of participants

      1 1 Normal liver function 8-12

      1 2 Moderate liver impairment Up to 8

      2 3 Severe liver impairment Up to 8

      The study will include three phases. A Screening phase, a Study Treatment phase, and a Follow-up phase.

      The screening assessment will be performed within 21 days before the first dose. After your screening period, if you are eligible, you will need to visit the study site at least every 3 weeks to receive the study treatment and take part in additional exams, tests, or procedures. Study drug will be infused through a vein over approximately 30 minutes starting at a 2.5 mg/kg dose in Part 1 (Groups 1 and 2) and potentially at a lower dose in Part 2 (Group 3) with doses calculated on your body weight at the time of dosing. Study visits will take as little as 3 hours or as much as 12 hours of your time.

      Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

      Some of the eligibility criteria include:

      •Age of at least 18 years

      •Diagnosis of RRMM

      Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

      Singhal, SeemaSinghal, Seema
      • Map it 251 E. Huron St.
        Chicago, IL
      NCT04398680 STU00213494
      More Info
      Copy
      (xIRB) NCI CIRB SWOG 1823: A Prospective Observational Cohort Study to Assess mRNA 371 for Outcome Prediction in Patients with Newly Diagnosed Germ Cell Tumors

      The purpose of this study is for the study doctors to learn if miRNA 371 is useful for predicting relapse

      in patients with germ cel…

      The purpose of this study is for the study doctors to learn if miRNA 371 is useful for predicting relapse

      in patients with germ cell cancer. A germ cell tumor is a type of cancer that occurs in the ovaries (for females) or the testes (for males). This tumor may also be found in the pelvis along the tailbone, the chest, the abdomen and in other structures of the body, generally along the midline of the body.

      A sample of your blood will be collected during regular clinic visits to look for the presence of a tumor marker called miRNA 371. The study doctors do not know if the test is as good as the usual care (tumor scans and bloodwork) in predicting when cancer will return (relapse) in patients with germ cell cancer. If better, this blood test could change the way patients are monitored for relapse in the future.

      If you decide to take part in this study, an extra tube of blood will be collected during your regular clinic visits for miRNA 371

      analysis for up to 3 years from enrollment into the study.

      Participants 18 years of age or older who have germ cell cancer will be enrolled.

      Kundu, Shilajit DKundu, Shilajit D
      • Map it 201 E. Huron St.
        Chicago, IL
      STU00213585
      More Info
      Copy
      DRUG ME-522-001: A Phase 1, Open-Label, Study of Voruciclib in Subjects with Relapsed and/or Refractory B Cell Malignancies or Acute Myeloid Leukemia After Failure of Prior Standard Therapies
      This study has been designed to look at the safety of voruciclib (also known as the study drug), how your bod…
      This study has been designed to look at the safety of voruciclib (also known as the study drug), how your body tolerates the drug, how effective the drug may be, and how the drug is taken up by your body when administered orally after multiple doses over the course of the study. This study is being conducted to determine the highest safely tolerated dose of voruciclib in patients that have relapsed and/or refractory B cell type cancers or acute myeloid leukemia.
      Must be diagnosed with a certain type of B cell cancer or acute myeloidleukemia (AML) that has relapsed (come back) or is refractory (did not respondto previous treatment). The types of B cell cancers in this study includefollicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma(MZL), small lymphocytic lymphoma (SLL), chronic lymphocytic leukemia (CLL), ordiffuse large B-cell lymphoma (DLBCL).
      Frankfurt, OlgaFrankfurt, Olga
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03547115 STU00213009
      More Info
      Copy
      DRUG AT148002: A Phase 1/2 Study of ALX148 in Combination with Azacitidine in Patients with Higher Risk Myelodysplastic Syndrome (MDS)
      The purpose of this research study is to learn about the effects of the study drug, ALX148, in combination with azacitidine (AZA), a standard treatment for MDS. The s…
      The purpose of this research study is to learn about the effects of the study drug, ALX148, in combination with azacitidine (AZA), a standard treatment for MDS. The study is being done to assess the safety and tolerability of ALX148, to document the levels of ALX148 in the blood, and to document the effects of ALX148 on your cancer when given together with AZA.

      This Phase 1/2 study includes two parts. In the Phase 1 part of this study, increasing doses of ALX148 will be given together with AZA. In the Phase 2 part of the study, ALX148 will be given at a dose selected from the Phase 1 part in combination with AZA. Depending on the timing, you will participate in either the Phase 1 or Phase 2.

      You will continue to receive treatment in the study as long as: you benefit from study treatment; you do not experience severe side effects; and you are willing to continue to undergo study-specific assessments. There is a 14-day screening period that will begin when you sign the consent form (up to 14 days before your first dose of ALX148), and a follow-up period for up to 3 years after your last dose of ALX148.

      This study will consist of a screening visit(s) and multiple cycles of study treatment and evaluation that will involve multiple visits to the clinic, an end of study visit, and a follow-up visit(s). ALX148 is administered by an intravenous (through a vein) infusion lasting approximately 60-90 minutes in the clinic. AZA will be given once daily either by vein or by injection under the skin for 7 days, every 4 weeks.

      The ALX148 study drug will be administered either every 2 or 4 weeks. AZA will be administered once daily for 7 days, every 4 weeks. A treatment cycle is 28 days both for ALX148 dosing every 2 or 4 weeks. It is possible that your treatment schedule may be changed. For example, your study doctor may start you on an every 4 week schedule and then change the schedule to every 2 weeks based on how well you tolerate the drug.

      Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

      Some of the eligibility criteria include:

      •Age of at least 18 years

      •Diagnosis of higher risk myelodysplastic syndrome (MDS) that is either no longer responsive to standard therapies of proven effectiveness and/or for which new safe and effective therapies need to be developed to improve outcomes.

      Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

      Altman, Jessica KAltman, Jessica K
      • Map it 251 E. Huron St.
        Chicago, IL
      NCT04417517 STU00213414
      More Info
      Copy
      DRUG ELVCAP-001-01: A Phase 2 Study of Seribantumab in Adult Patients with Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors

      The purpose of this study is to test an experimental drug called seribantumab. This means that seribantumab is still being studied to better un…

      The purpose of this study is to test an experimental drug called seribantumab. This means that seribantumab is still being studied to better understand the potential efficacy and safety of the drug. It also means that the U.S. Food and Drug Administration (FDA) or regulatory authorities from other countries do not allow it to be sold for treating patients. Seribantumab can only be used in research and on a clinical research trial. This study is being done:

      •To determine how well your NRG1 gene fusion positive cancer responds to treatment with seribantumab;

      •To determine how long any benefits from treatment with seribantumab last;

      •To determine the highest and safe dose of seribantumab for NRG1 fusion patients

      •To evaluate how the body absorbs and processes different doses of seribantumab (this is called pharmacokinetic (PK) testing);

      •To see if certain biomarkers from tumor tissue or blood samples are linked with positive or negative response outcomes

      This is an open-label study. This means that you, the study doctor, study staff, and the Sponsor will know the study drug and the doses that you are given.

      The length of the study will vary for each person and will be determined by the number of treatment cycles. Overall, you should expect to be on treatment for at least six months or longer. The number of study-visits you will have will be based on the following schedule:

      •Screening period: One or more visits for up to 28 days

      •Induction Treatment period: Weekly visits for 4 weeks.

      •Consolidation Treatment period: Every other week visits for 12 weeks and a total of 6 visits.

      •Maintenance Treatment period: Visits every three weeks until you end your treatment.

      If you are eligible, after the screening period, you will receive treatment with study drug once every 7-days for a total of four weeks. When you start treatment, you will be given an initial amount of seribantumab during your first visit. For your second, third and fourth visits during treatment, the dose of seribantumab will be adjusted based upon how well you and other patients tolerate the planned induction dose. Your study doctor and study team will let you know what dose you will receive for the second, third and fourth induction treatment visits.

      You will receive an infusion of the study drug directly into your vein. This is done by inserting a small hollow tube into a vein in your arm. The tube is placed into the vein with a needle. When the tube is in place, the needle is withdrawn, and the tube is secured with tape. The infusion will take about 60 minutes. Following the study drug infusion, your study doctor may require you to stay in the study clinic for up to an hour or longer, so that he/she can monitor you.

      Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

      Some of the eligibility criteria include:

      •Age of at least 18 years

      •Diagnosis of advanced or metastatic tumor that is believed to be caused by a change in the NRG1 gene called a fusion

      Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

      Chae, Young KwangChae, Young Kwang
      • Map it 251 E. Huron St.
        Chicago, IL
      NCT04383210 STU00213426
      More Info
      Copy
      (xIRB) NCI CIRB ETCTN 10367: A Phase 1b Study with Expansion Cohort of Escalating Doses of KRT-232 (AMG 232) Administered in Combination with Standard Induction Chemotherapy (Cytarabine and Idarubicin) in Newly Diagnosed Acute Myelogenous Leukemia (AML)

      The purpose of this study is to test the saf…

      The purpose of this study is to test the safety and tolerability (side effects) of adding a

      study drug called KRT-232 (AMG 232) at different doses to standard treatment with cytarabine

      and idarubicin. This study tests different doses of the drug to see which dose is safer and

      more tolerable for people. Another purpose of the study is to check the level of the study drugs

      in the blood (pharmacokinetics). In addition, another objective of the study is genetic testing

      using tumor tissue to see if the combination of drugs may work in treating this type of cancer.

      This is the first time these drugs will be tested together in humans and therefore this is not

      approved by the FDA for treatment of AML.

      There are two parts in this study, a dose escalation part and a dose expansion part.

      You will only be enrolled into one part of the study. In the dose escalation part of this study,

      different people will get different doses of the study drug KRT-232 (AMG 232) along with cytarabine

      and idarubicin. The doses will continue to increase for every new group until people have serious

      side effects that require the dose to be lower. Once this dose is found, the dose escalation is

      stopped. In the dose expansion part of this study, the highest dose with manageable side effects

      will be given along with cytarabine and idarubicin. The dose of the study drug might be decreased

      or kept the same depending on the side effects. This will help study doctors better understand the

      side effects that may happen with this drug.

      Participants will only receive the study drug, KRT-232 (AMG 232), along with cytarabine and idarubicin

      during the first cycle and second cycle of treatment. Participants will receive the study drug until

      their disease progresses, or the side effects become too severe. If you stop the study but your

      disease has not gotten worse, you will have a bone marrow aspirate/biopsy assessment of your AML every

      3 months for 2 years until your disease gets worse or you begin a different treatment.

      After that, the doctor or study team will follow up every six months (either in person or by phone call).

      Participants 18 years of age or older who have newly diagnosed acute myeloid leukemia (AML).

      Altman, Jessica KAltman, Jessica K
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04190550 STU00213763
      More Info
      AML
      Copy
      (xIRB) NCI CIRB SWOG 1929: Phase II Randomized Study of Maintenance Atezolizumab Versus Atezolizumab in Combination with Talazoparib in Patients with SLFN11 Positive Extensive Stage Small Cell Lung Cancer (ES-SCLC)

      The purpose of the study is to determine if researchers can lower the

      The purpose of the study is to determine if researchers can lower the

      chance of small cell lung cancer growing or spreading by adding talazoparib to the usual atezolizumab

      treatment. Researchers want to find out if this approach is better or worse than the usual approach

      for small cell lung cancer.

      This study has two parts: a screening part and a treatment part. The purpose of the screening

      part is to test your tumor to find out if it has a protein, SLFN11.

      If it does and you meet all the study requirements, then you will be randomized to a study group

      for treatment. The purpose of the treatment part of the study is to compare the usual

      treatment (atezolizumab) alone to using talazoparib plus the usual treatment. This immunotherapy drug,

      atezolizumab, is already approved by the FDA for use in ES-SCLC cancer.

      The treatment part of the study has two groups:

      Group 1

      Participants in group 1 will be given atezolizumab.

      Group 2

      Participants in group 2 will get talazoparib plus atezolizumab.

      After you finish your treatment, your doctor and study team will watch you for side effects.

      They will check you every 6 months for 2 years and at the end of year 3 from the start of treatment.

      This means you will keep seeing your doctor for up to 3 years from the time you start treatment.

      Participants aged 18 years or older who have extensive stage small cell lung cancer (ES-SCLC) will

      participate in this study.

      Chae, Young KwangChae, Young Kwang
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04334941 STU00213765
      More Info
      Copy
      Serial Monitoring of Circulating Tumor Cells During Radiotherapy for Women with Non-Metastatic Breast Cancer: A Prospective Observational Cohort Study

      The purpose of this research is to determine whether radiotherapy after surgery to remove a breast cancer can help decrease the number of circulati…

      The purpose of this research is to determine whether radiotherapy after surgery to remove a breast cancer can help decrease the number of circulating tumor cells (CTCs) in the blood. Circulating tumor cells are cancer cells that are shed from the tumor into the blood stream and are believed to be one of the first indicators that breast cancer cells may remain after surgery. Approximately 20% of women with early-stage breast cancer can be found to have CTCs in a small sample of blood taken several weeks after surgery. Radiotherapy is used after surgery to remove a breast cancer in order to sterilize any cancer cells that may be remaining in the breast. It is not known if radiotherapy can help decrease or eliminate CTCs that are found in the blood. This study aims to find out if testing for CTCs can be clinically useful for guiding radiotherapy treatment decisions. Another aim of this study is to evaluate whether CTCs can be used to measure the effectiveness of radiotherapy in an individual patient.

      Eligible participants are post-menopausal women that have been diagnosed with non-metastatic, ER-positive and Her2-nonamplifed breast cancer and are planning on receiving radiation and hormone therapy.

      Strauss, Jonathan BStrauss, Jonathan B
      • Map it 201 E. Huron St.
        Chicago, IL
      STU00212971
      More Info
      Copy
      NRG BN007: A Randomized Phase II/III Open-Label Study of Ipilimumab and Nivolumab Versus Temozolomide in Patients with Newly Diagnosed MGMT (Tumor O-6-Methylguanine DNA Methyltransferase) Unmethylated Glioblastoma
      This study is being done to answer the following question: Can we lengthen time without…
      This study is being done to answer the following question: Can we lengthen time without your brain tumor returning or growing and can we extend your life by replacing the usual chemotherapy with immune therapy? We are doing this study because we want to find out if this approach is better, the same, or worse than the usual approach for your brain tumor. The usual approach is defined as care most people get for glioblastoma brain tumors.
      • Participants must be 18 years or older
      • Participants must have a confirmed diagnosis of newly diagnosed Glioblastoma with a specific biomarker known as unmethylated MGMT.
      Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
      Dixit, Karan SinghDixit, Karan Singh
      • Map it 251 E. Huron St.
        Chicago, IL
      NCT04396860 STU00213865
      More Info
      Copy
      (xIRB) NCI CIRB ETCTN 10389: A Phase 1 Trial Combining WEE1 Inhibitor Adavosertib (AZD1775) with Radiation Therapy for Metastatic or Inoperable and Ineligible for Definitive Chemoradiation Esophageal and Gastroesophageal Junction Cancer

      The purpose of this study is to test the safety and tolerabil…

      The purpose of this study is to test the safety and tolerability (side effects) of adding a

      study drug called AZD1775 at different doses along with standard radiation treatment.

      This study tests different doses of the study drug when given with radiation at various times to see

      which dose is safer and more tolerable for people. Researchers want to find out what effects

      (good or bad) the drug has on people, if any. In addition, another objective of the study is to

      perform genetic testing on tumor tissue to determine if certain genetic changes in the tumor help

      predict who will respond to the drug. This drug, either alone or in combination with radiation,

      is not approved by the FDA for treatment of this type of cancer.

      There are two parts in this study, a dose escalation part and a dose expansion part.

      Participants will only enroll into one part of the study.

      In the dose escalation part of this study, different people will get different doses of the study drug

      AZD1775. The doses will continue to increase for every new group until reaching the highest planned

      dose.

      In the dose expansion part of this study, the highest dose with manageable side effects will be given

      to participants who are enrolled. This will help study doctors better understand the side effects

      that may happen with this drug.

      Participants will get the study drug, AZD1775, alone for one week, and then in combination with

      standard radiation therapy for up to three weeks (one cycle) of treatment, or until the side effects

      become too severe for those enrolled in the dose escalation part of this study.

      Participants in the dose expansion part of this study will get the study drug, AZD1775, for one week

      followed by 3 weeks of combination study drug and radiation therapy.

      Participants will be checked for side effects three weeks after completing treatment with a

      clinic visit and then clinic visits will occur every 3 months for 2 years after treatment.

      After that, participants will be checked for side effects with clinic visits every 6 months

      for 3 years, for a total of 5 years after treatment.

      Participants 18 years of age or older who have esophageal cancer and gastroesophageal junction

      cancer that is not able to be treated with surgery or with chemotherapy and radiation therapy given

      at the same time or that has spread to other parts of the body.

      Mulcahy, Mary FrancesMulcahy, Mary Frances
      • Map it 201 E. Huron St.
        Chicago, IL
      STU00213892
      More Info
      Copy
      ECOG-ACRIN 9181: A Phase III Randomized Trial of Steroids + Tyrosine Kinase Inhibitor Induction with Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults
      This study is being done to answer the following question: This study is being done to determin…
      This study is being done to answer the following question: This study is being done to determine what effects (good or bad) using the combination of potent TKI, steroids and blinatumomab versus treatment with steroids, TKI and chemotherapy. This investigational therapy will be added to what has traditionally been used to treat your specific sub-type of ALL. Studies are being done in ALL and other blood cancers with blinatumomab. We are doing this study because we want to find out if this approach is better or worse than the usual approach for you. The usual approach is defined as care most people get for ALL.
      • Participants must be 18 years or older
      • Participants must have a confirmed diagnosis of newly diagnosed BCR-ABL-positive Acute Lymphoblastic Leukemia (ALL).
      Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
      Dinner, Shira NaomiDinner, Shira Naomi
      • Map it 251 E. Huron St.
        Chicago, IL
      NCT04530565 STU00213941
      More Info
      Copy
      (xIRB) NCI CIRB ECOG-ACRIN 8191: Phase III Study of PET-Directed Local or Systemic Therapy Intensification in Prostate Cancer Patients with Post-Prostatectomy Biochemical Recurrence

      The purpose of this study is to compare the usual treatment alone

      to using PET/CT imaging to look for cancer …

      The purpose of this study is to compare the usual treatment alone

      to using PET/CT imaging to look for cancer that has spread to the pelvis plus the usual treatment.

      We want to see if we can provide a more targeted treatment to this type of cancer by treating up to 5

      specific lesions that are seen on the PET/CT scan. Part of the purpose of this study is also to see

      whether adding apalutamide and directed radiation works better than the usual approach to help treat

      prostate cancer that has returned after surgery.

      This study will help the study doctors find out if this different approach is better than the usual

      approach. To decide if it is better, the study doctors will be looking to see if the study approach

      increases the time before cancer growth or if the cancer causes major additional symptoms.

      This study has 4 study groups. Participants will be assigned to 1 of 4 possible treatment groups

      depending on the results of your PET/CT scan. After you finish your study treatment, your doctor will

      continue to follow your condition for up to 10 years and watch you for side effects and monitor the

      progression of your cancer.

      Group 1 (Negative for Extra Pelvic-Metastases)

      If you are in this group, it means your PET/CT scan did not show evidence that your cancer has spread

      to outside of the pelvis. You will get the usual appropriate care that is used to treat this type of

      cancer, the planned standard of care treatment with radiation therapy (SOC RT) and STAD for 6 months.

      Group 2 (Negative for Extra Pelvic-Metastases)

      If you are in this group, it means your PET/CT scan did not show evidence that your cancer has spread

      to areas outside of the pelvis. You will get a study treatment, planned SOC RT + STAD + apalutamide

      for 6 months.

      Group 3 (Positive for Extra Pelvic-Metastases)

      If you are in this group, it means that your cancer has spread to areas outside of your pelvis.

      You will get planned SOC RT + STAD + apalutamide for 6 months.

      Group 4 (Positive for Extra Pelvic-Metastases)

      If you are in this group, your cancer has spread to areas outside of your pelvis.

      You will get a planned SOC RT + STAD + apalutamide for 6 months + directed radiation therapy to

      where the cancer has spread. Each patient will undergo another (or additional) PET/CT scan,

      which will take place about one year after starting treatment or if clinically necessary at an

      earlier time point.

      Male participants 18 years of age or older who have prostate cancer that has come back after surgery

      will be enrolled into this study.

      Morgans, Alicia KatherineMorgans, Alicia Katherine
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04423211 STU00214021
      More Info
      Copy
      DRUG Q702-ONC-P1-US001 A Phase 1 Multicenter, Open-label, Dose-Escalation, Safety, Pharmacodynamic, Pharmacokinetic Study of Q702 with a Cohort Expansion at the RP2D in Patients with Advanced Solid Tumors
      The major purpose of this study is to determine the highest dose of Q702 that does not result in…
      The major purpose of this study is to determine the highest dose of Q702 that does not result in severe side effects, the dose that is tolerated, and once this dose is found, if it has any effect against the cancer in patients with solid cancer tumors. This study is being done:

      • To test the safety of Q702 and see what effects (good and bad) it has on you and your cancer.
      • To find the highest dose of Q702 that can be given without causing serious side effects when treatment is given every day for 7 days, followed by 7 days of no treatment, repeated two times during a 28-day cycle.
      • To find the dose of Q702 that should be used in future studies.
      • To evaluate what the human body does and how the body reacts to Q702.

      This research is being performed because improvements are needed in the treatment of patients with cancer.

      We are asking you to take part in this research study because you have cancer that has continued to grow despite the treatments you have already received. Either the standard drugs and therapies used to treat your disease are no longer working or there are no known treatments which work because your tumor cells may be resistant to available treatments or you are not a candidate for or intolerant of available treatment. Your cancer had been confirmed by a pathologist (a person who studies the causes and effects of diseases).

      This clinical trial tests a study drug, Q702. The study drug, Q702, targets certain molecules present in cancer cells that may help activate your body's immune system to fight the cancer. The study drug, Q702, is not approved for sale by the FDA.

      Mahalingam, DevalingamMahalingam, Devalingam
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04648254 STU00213510
      More Info
      Copy
      (xIRB) NCI CIRB Alliance A071702: A Phase II Study of Checkpoint Blockade Immunotherapy in Patients with Somatically Hypermutated Recurrent Glioblastoma

      The purpose of this study is to test the good and bad effects of the combination of immunotherapy drugs

      called nivolumab and ipilimumab. T…

      The purpose of this study is to test the good and bad effects of the combination of immunotherapy drugs

      called nivolumab and ipilimumab. The study doctors hope to learn if the study drugs will lead to a

      stability or reduction in the size of your tumor.

      Nivolumab and Ipilimumab have already been approved by the FDA to treat other cancers.

      In this study, if your tumor has a higher number of mutations, you will receive a combination of

      nivolumab and ipilimumab every three weeks for four cycles and then you will receive nivolumab alone

      every four weeks as long as you keep responding to it and do not experience any serious side effects.

      If your tumor starts to grow while receiving the medication, we will stop treating you with it.

      After you finish your study treatment, your doctor will continue to follow your condition every 3

      months for 3 years and watch you for side effects.

      Participants age 18 years or older who have a glioblastomawhich has recurred (come back) or gotten bigger after initial treatment will beenrolled into this study.

      Kumthekar, Priya UKumthekar, Priya U
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04145115 STU00214358
      More Info
      Copy
      (xIRB) NCI CIRB NRG BN009: Phase III Trial of Salvage Stereotactic Radiosurgery (SRS) or SRS + Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for First or Second Distant Brain Relapse After Upfront SRS With Brain Metastasis Velocity >/= 4 Brain Metastases/Year

      The purpose of this study is…

      The purpose of this study is to compare the usual treatment of SRS alone to SRS plus HA-WBRT

      (whole brain radiation therapy with hippocampus avoidance) and memantine for patients with cancer

      that has spread to the brain and come back in other areas of the brain after earlier treatment with SRS.

      The addition of HA-WBRT and memantine to the usual treatment could better control your brain cancer.

      This study will help the study doctors find out if this different approach is better, the same,

      or worse than the usual approach.

      Memantine is FDA approved for treating dementia and is commonly used off-label

      (that is, for a purpose for which it is not FDA approved) for patients receiving whole-brain

      radiation therapy for cancer that has spread to the brain.

      This study has 2 study groups. You will be told which group you are in.

      Group 1

      If you are in this group, you will get the usual treatment, SRS. In addition to the usual

      SRS treatment, you will also receive HA-WBRT. You will also be given the drug memantine,

      which has also been shown to preserve memory function. Memantine will be taken for up to 6 months.

      Group 2

      If you are in this group, you will get the usual treatment of SRS.

      After you finish your treatment, your doctor and study team will watch you for side effects and

      follow your condition. They will check you every 2 to 3 months for at least 1 year after you finish

      SRS. If you are receiving memantine, your doctor will continue to see you in the clinic as needed.

      Participants age 18 years or older who have receivedstereotactic radiosurgery to treat cancer that spread to the brain, and now thecancer has returned in other areas of the brain will be enrolled into thisstudy.

      Lukas, Rimas VincasLukas, Rimas Vincas
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04588246 STU00214371
      More Info
      Copy
      DRUG ITM-LET-01 : A prospective, randomised, Controlled, Open-label, Multicentre phase III study to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somato-statin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).
      This study aims to compare two different treatment options: the current routine treatment with orally administered everolimus on the one hand and on the other hand, a new treatment option called Peptide Receptor Radionuclide Therapy (shortly PRRT). The PRRT that is being studied is based on the administration of the radioactive pharmaceutical 177Lu-edotreotide. The aim of both treatment arms is to slow or stop tumor progression or even to reduce tumor sizes. By inclusion of both, 1st line (patients having had no disease treatment before) and 2nd line (patients having been treated before) GEP-NET patients, the issue of optimum timing of PRRT during the disease course will also be addressed by the present trial.
      Patients who are of 18 years of age or older may be able to take part in this study is they have inoperable, progressive, somato-statin receptor-positive (SSTR+), neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NET).
      Benson III, Al BBenson III, Al B
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03049189 STU00213444
      More Info
      Copy
      (xIRB) NCI CIRB ECOG-ACRIN 8183: A Phase III Double Blinded Study of Early Intervention After RADICAl ProstaTEctomy with Androgen Deprivation Therapy with Darolutamide vs. Placebo in Men at Highest Risk of Prostate Cancer Metastasis by Genomic Stratification (ERADICATE)

      The purpose of thisstudy is…

      The purpose of thisstudy is to compare Androgen Deprivation Therapy (ADT) alone to ADT plusdarolutamide for participants who have had surgery for prostate cancer. Thisstudy will help the study doctors find out if this different approach worksbetter than the approach of ADT alone. To decide if it is better, the studydoctors will be looking to see if the darolutamide increases the life of patientsby 6 months or more compared to the usual approach.

      This study has 2groups. Participants will not be told which group they are in.

      Group 1: Participantsin group 1 will get ADT plus a placebo pill for up to 12 months. A placebo is apill that looks like the study drug but contains no medication.

      Group 2: Participants ingroup 2 will get ADT plus darolutamide. Darolutamide is not approved by the FDAfor treatment of this type of disease.

      After study treatmentis finished, participants will be followed for 3-month intervals for 36 months towatch for side effects and disease progression.

      Male participants ages 18 years or older who have had surgery forprostate cancer will be enrolled in this study.
      Ross, Ashley EvanRoss, Ashley Evan
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04484818 STU00214490
      More Info
      Copy
      (xIRB) NCI CIRB ECOG-ACRIN 2197: Optimal Perioperative Therapy for Incidental Gallbladder Cancer (OPT-IN): A Randomized Phase II/III Trial

      The purpose of this study is to compare the usual treatment(surgery plus chemotherapy after) to using chemotherapy both before and aftersurgery.

      This st…

      The purpose of this study is to compare the usual treatment(surgery plus chemotherapy after) to using chemotherapy both before and aftersurgery.

      This study will help the study doctors find out if thisdifferent approach is better than the usual approach. To decide if it isbetter, the study doctors will look to see if the chemotherapy increases thetime to disease recurrence and if it increases a patient’s overall survivalcompared to the usual approach given both before and after surgery.

      There are two groups in this study.

      Group 1 (Control Arm-Arm A) receives surgery and then 6 monthsof chemotherapy (gemcitabine/ cisplatin) after surgery.

      Group 2 (Treatment Arm-Arm B). In Group 2, participants willreceive 3 months of chemotherapy) prior to undergoing surgery, followed by 3months of chemotherapy after undergoing surgery.

      Participants will be randomly assigned to one group or theother. In Group 2, there will be a waiting period of approximately 4-8 weeksafter completion of chemotherapy before undergoing surgery. Only patients whohave not progressed with disease outside the area of the surgery will proceedto surgery.

      After all the treatment is done, participants will havefollow-up procedures with imaging studies (CT and/or MRI) every 3 months for 2years and every 6 months for year 3 after treatment or until diseaserecurrence, whichever comes first.

      Participants ages 18 years or older who have recently been diagnosedwith gallbladder cancer that was found after their gallbladder was removedduring surgery.
      Chawla, AkhilChawla, Akhil
      • Map it 201 E. Huron St.
        Chicago, IL
      STU00214491
      More Info
      Copy
      (xIRB) NCI CIRB Alliance A091902: A Multicenter Phase II Trial of Paclitaxel with and Without Nivolumab in Taxane Naïve, and Nivolumab and Cabozantinib in Taxane Pretreated Subjects with Angiosarcoma

      The purpose of thisstudy is to compare treatment with chemotherapy (paclitaxel) alone to using ac…

      The purpose of thisstudy is to compare treatment with chemotherapy (paclitaxel) alone to using acombination of nivolumab plus chemotherapy (paclitaxel) treatment inparticipants with angiosarcoma who have not been treated with paclitaxel chemotherapyalone. Another purpose is to evaluate the effect of nivolumab in combinationwith cabozantinib on angiosarcoma (cancer) in participants who have eitherreceived paclitaxel or similar chemotherapy previously, or whose cancer hasgrown previously while getting paclitaxel chemotherapy on this study.

      This study has 2 study groups.

      Participants enrolledinto group 1 are those who have not received prior chemotherapy treatment withpaclitaxel or similar “taxane” chemotherapy. In this group, participants willbe assigned to one of two arms. In Arm 1, participants will receive combinationof paclitaxel and nivolumab. Participants assigned to Arm 2, will only receivepaclitaxel.

      You will be put into astudy arm by chance. You will have a 50:50 chance of being in Arm 1 or Arm 2.If you are assigned to Arm 2 and your cancer gets worse you will have thechoice to receive cabozantinib and nivolumab if your doctor feels it wouldbenefit you.

      Participantsenrolled into group 2 are those that have received prior chemotherapy treatmentwith paclitaxel or a similar “taxane” chemotherapy or participants who progresswhile in Group 1. In this group, participants will receive a combination ofcabozantinib and nivolumab.

      After treatment is finished, participants will be followed every3 months for 3 years to be watched for side effects.

      Participants ages 18 years or older who have a type of cancer called angiosarcoma.
      Pollack, Seth MichaelsPollack, Seth Michaels
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04339738 STU00214492
      More Info
      angiosarcoma
      Copy
      (xIRB) NCI CIRB ECOG-ACRIN 3161: A Phase II/III Randomized Study of Maintenance Nivolumab versus Observation in Patients with Locally Advanced, Intermediate Risk HPV Positive OPCA

      The purposeof this study is to compare the usual treatment alone, radiation andchemotherapy (cisplatin), to adding mai…

      The purposeof this study is to compare the usual treatment alone, radiation andchemotherapy (cisplatin), to adding maintenance nivolumab to the usualtreatment. The addition of nivolumab to the usual treatment could shrinkintermediate risk HPV positive oropharynx cancer or prevent it from returning. Thisstudy will help determine if maintenance nivolumab following definitive therapywith radiation and chemotherapy (cisplatin) result in significant improvementin overall survival (time being alive) and progression-free survival (timebeing alive without cancer) for patients with intermediate risk HPV positiveoropharynx cancer.

      Each patient will receivetreatment based on the group by which they are assigned. In Group 1, patientswill receive chemotherapy weekly for up to 7 weeks and radiation dailyexcluding weekends, for up to 7 weeks. Then the patient will either getnivolumab by vein (intravenously) every 4 weeks for up to 12 months and bemonitored and observed. In Group 2, patients will receive chemotherapy andradiation in the same way as in Group 1 but will be monitored and observedwithout getting nivolumab. However, if the cancer grows during observation, thenGroup 2 patients will be offered nivolumab by vein (intravenously) every 4weeks for up to 12 months.

      After treatment is complete, thedoctor and study team will watch patients for side effects. They will check patients every 3-6 months for3 years after treatment. After that,they may check patients every year. This means patients may keep seeing thedoctor for 10 years after treatment.

      •Age of at least 18 years

      •For Step 1 – Patients must have oropharynx cancer (AJCC 8) that is p16-positive by immunohistochemistry with smoking status: ≥10 pack-years, stage T1-2N2-N3 or T3-4N0-3 (less than 10 packyears is considered a non-smoker)

      OR

      <10 pack-years, stage T4N0-N3 or T1-3N2-3.

      •For Step 2 – Patients must have progression per RECIST criteria AND tissueproven progression on Arm B treatment within 12 months after completion of radiation therapy

      Boumber, YanisBoumber, Yanis
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03811015 STU00214496
      More Info
      Copy
      (xIRB) NCI CIRB ETCTN 10330: A Phase 2 Study of Belinostat and SGI-110 (Guadecitabine) for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma

      The purposeof this study is to test the good and bad effects of the drugs calledbelinostat and SGI-110 (guadecitabine), and to determi…

      The purposeof this study is to test the good and bad effects of the drugs calledbelinostat and SGI-110 (guadecitabine), and to determine if the combination ofdrugs belinostat and SGI-110 are effective at lowering the chance ofchondrosarcoma growing or spreading compared to the usual care forchondrosarcoma cancer.

      If enrolledin this study, patients will receive the study drugs belinostat and SGI-110(guadecitabine). Patients will receive bilinostat and SGI-110 (guadecitabine)on days 1 through 5 of each cycle. Some procedures involved in this studyinclude blood draws, biopsies, imaging tests and genetic testing.

      Each patient will receive twodrugs, belinostat and SGI-110 (guadecitabine). Belinostat is administered through a vein in the arm (IV) overapproximately 30 minutes, and SGI-110 (guadecitabine) is administered bysubcutaneous injection (i.e., under the skin). Both drugs will be given together, once daily for 5 consecutive days inthe doctor’s office. This 5-daytreatment is repeated every 28 days. Thetreatment will continue for as long as the disease remains controlled, nounacceptable side-effects are developed, and the patient still wants tocontinue participating in the study.

      The status of the cancer willbe evaluated by imaging tests (e.g., by a CT scan or an MRI scan) every 8 weekswhile patients are receiving the treatment. After treatment is completed forthe study, the study team will follow up with patients in the clinic or bytelephone approximately once every 3 months for information related to thestatus of the cancer and any new treatments patients might be receiving, for aperiod of up to 24 months.

      •Age ≥18 years.

      •Patients must have biopsy-proven conventional chondrosarcoma (CS) which is:

      -either metastatic or locally advanced and unresectable, and

      -measurable at study entry according to RECIST version 1.1 criteria, and

      -amenable to biopsy with imaging guidance at no or acceptable risk to the patient as

      defined by institutional guidelines for research-related biopsies or the treating investigator’s assessment.

      •Patients must have at least one lesion measurable by RECIST version 1.1 criteria

      which has not been previously irradiated.

      Pollack, Seth MichaelsPollack, Seth Michaels
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04340843 STU00214562
      More Info
      Copy
      (xIRB) NCI CIRB SWOG 1931: Phase III Trial of Immunotherapy-Based Combination Therapy with or Without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma (PROBE Trial)

      The purpose of this study isto compare Standard Systemic Therapy (SST) alone to SST plus surgery to removeall or part of…

      The purpose of this study isto compare Standard Systemic Therapy (SST) alone to SST plus surgery to removeall or part of the kidney with tumor. All patients receive SST to shrink the tumor and stimulate the immunesystem. Participants who are benefiting from this treatment will be selected bychance to have surgery and then continue SST or continue SST without surgery. Thisstudy will help the study doctors find out which approach is better, the same,or worse.

      Participantswho decide to take part in this study will get either only standard drugcombination therapy or will get the standard drug combination therapy andsurgery to remove part or all of their kidney. Participants will get treatment until their disease gets worse.

      After study treatmentis completed, participants will be followed for up to 7 years to watch for sideeffects.

      All of the drugs that are usedas part of treatment on this study are commercially available, FDA approved,and considered standard treatment for this type of kidney cancer.

      Participants ages 18 years or older who havekidney cancer that has spread outside of the kidney will participate in this study.
      Sosman, Jeffrey AlanSosman, Jeffrey Alan
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04510597 STU00214655
      More Info
      kidney SST
      Copy
      (xIRB) NCI CIRB ECOG-ACRIN 8185: Phase 2 Study of Bladder-SparIng ChemoradiatioN with MEDI4736 (Durvalumab) in Clinical Stage 3, Node PosItive BladdeR CancEr (INSPIRE)

      The purpose of this study is to compare the usual treatment of chemotherapy and radiation to adding MEDI4736 (durvalumab) immunoth…

      The purpose of this study is to compare the usual treatment of chemotherapy and radiation to adding MEDI4736 (durvalumab) immunotherapy to the usual treatment. This study will help determine if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the life of patients compared to the usual approach.

      This immunotherapy drug,MEDI4736 (durvalumab), is already approved by the FDA for use in metastatic bladder cancer.

      Participants who decide to take part in this study will either get chemotherapy and radiation for 6-8weeks, or will get MEDI4736 (durvalumab) immunotherapy in addition to chemotherapy and radiation for 6.5-8 weeks. Participants in the MEDI4736(durvalumab) Group 1 whose bladder cancer has responded (shrunk, gone away or remained stable) to treatment with chemotherapy, radiation and MEDI4736(durvalumab) will be offered more treatments with MEDI4736 (durvalumab) alone for up to 9 months.

      Participants who are in the arm with chemotherapy and radiation, and whose cancer has responded, will be watched closely without any additional chemotherapy and radiation treatments. Participants whose cancer has not responded, may be offered surgery or some other treatment.

      After study treatment is finished, participants will be followed by the study doctor for up to 3 years.

      Participants ages 18 years or older who have bladder cancer that has spread from the bladder to the lymph nodes will be enrolled into this study.

      VanderWeele, David JamesVanderWeele, David James
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04216290 STU00214716
      More Info
      Copy
      (xIRB) NCI CIRB ETCTN 10422: A Phase 1/1b Dose Escalation Study of Abemaciclib and Olaparib for Recurrent Platinum-Resistant Ovarian Cancer

      The purpose of this study is to test the safety and tolerability (side effects) of abemaciclib in combination with olaparib at different doses. This study te…

      The purpose of this study is to test the safety and tolerability (side effects) of abemaciclib in combination with olaparib at different doses. This study tests different doses of the drugs to find the highest dose that can be given to people safely and tolerably. The combination of the drug abemaciclib and olaparib is not approved by the Food and Drug Administration (FDA) for ovarian cancer.

      There are two parts in this study, a dose escalation (or dose finding) and the dose expansion (where the established dose is further tested).

      In the dose escalation part of this study, different people will get different doses of the study drugs abemaciclib and olaparib.

      In the dose expansion part of this study, participants will receive the dose found to be safe in the first part of the study. This will help study doctors better understand the side effects that may happen with this drug.

      Participants will get olaparib, which will be given by mouth twice daily for 7days. Starting on Day 8 of Cycle 1, abemaciclib will be given with olaparib, orally twice a day until the disease gets worse, the side effects become too severe, the doctor believes it is no longer safe to receive the study drugs, or the participant’s desire to discontinue the study drugs.

      Participants will be followed for 30 days after treatment is finished to watch for side effects.

      Womenage 18 years or older who have ovarian cancer that has come back will beenrolled into this study.

      Barber, Emma LongleyBarber, Emma Longley
      • Map it 201 E. Huron St.
        Chicago, IL
      STU00214798
      More Info
      Copy
      (xIRB) NCI CIRB Alliance A011801: The COMPASSHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer): COMPASSHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared with T-DM1 and Tucatinib

      The purpose of this study is to compare the usual treatment with T-DM1 alone toT-DM1 plus tucatinib. This study will help the study doctors find out if this different approach is better than the usual approach. T-DM1 is already approved by the FDA for use in patients with HER2-positive cancer. Tucatinib has not been FDA-approved to treat breast cancer.

      Participants who decide to participate will either get treatment with T-DM1 and placebo (a pill that looks like the study drug but contains no medication) or T-DM1 and tucatinib, for up to 14 cycles, unless the breast cancer returns or the side effects become too severe.

      After study treatment is finished, the study doctor will follow participants to watch for side effects and for signs of breast cancer returning. This may include a clinic visit every 6 months for 10 years.

      Participants age 18 years or older who have HER2-positive breast cancer, and who have already received treatment with chemotherapy and anti-HER2 targeted therapies followed by surgery. At the time of the surgery, cancer was still present in the breast and/or lymph nodes and was removed by a surgeon, will be enrolled into this study.

      Stein, Regina MStein, Regina M
      • Map it 201 E. Huron St.
        Chicago, IL
      STU00214807
      More Info
      Copy
      (xIRB) NCI CIRB ETCTN 10387: Pilot Trial of Nivolumab Plus Cabozantinib for Advanced Solid Tumors in Patients with HIV Infection

      The purpose of this study is to test the safety and tolerability (side effects) of a combination of drugs called XL184(cabozantinib) and nivolumab in people with cancer …

      The purpose of this study is to test the safety and tolerability (side effects) of a combination of drugs called XL184(cabozantinib) and nivolumab in people with cancer that are undergoing treatment for HIV. The combination of XL184 (cabozantinib) and nivolumab has not been approved by the FDA and are considered investigational when used in combination and when used in patients who are also undergoing treatment for HIV.

      There are two parts in this study, a safety run-in part and a dose expansion part. Participants will be told which part they are in.

      In the safety run-in part of this study, people will receive doses of the study drugs, XL184 (cabozantinib) and nivolumab, that are recommended for patients not being treated for HIV.

      In the dose expansion part of this study, the highest dose with manageable side effects will be given to participants with Kaposi sarcoma. This will help study doctors better understand the side effects that may happen with this drug.

      Participants who decide to enroll will get XL184 (cabozantinib) for 2 weeks, followed by a combination of XL184 (cabozantinib) and nivolumab for up to 1 year, or 6 months to 1 year until your tumor gets worse, your study doctor believes it is no longer working for you, you cannot tolerate the drugs, or you desire to discontinue the study drugs. You may be asked to change the medication that you are taking for your HIV to avoid possibly harmful medication interactions between the study agent and your HIV medication

      After you finish XL184 (cabozantinib) and nivolumab your doctor will continue to follow your condition for 16 more weeks and watch you for side effects, your cancer’s response to the medications, and any effects of the medications on HIV. This means you will keep seeing your doctor each month for approximately 4 months after you finish taking the study drugs.

      Participants 18 years or older who have advanced cancer and areundergoing treatment for HIV will be enrolled into this study.

      Pollack, Seth MichaelsPollack, Seth Michaels
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04514484 STU00214811
      More Info
      Copy
      Randomized Trial to Prevent Vascular Events in HIV – REPRIEVE (A5332)/ A5333s: Effects of Pitavastatin on Coronary Artery Disease and Inflammatory Biomarkers: Mechanistic Substudy of REPRIEVE/A5361s: Pitavastatin to REduce Physical Function Impairment and Frailty in HIV (PREPARE)
      People infected wi…
      People infected with HIV are at risk for cardiovascular disease (CVD). REPRIEVE is a large double-blind, randomized, placebo-controlled study of pitavastatin or placebo for about 72 months. The trial is testing the effect of statin therapy on preventing heart disease and death in HIV-infected persons on HIV medications who do not meet guidelines for starting statins. HIV causes inflammation (irritation) inside the body that may contribute to diseases such as heart disease. HIV medications can lower inflammation, however the levels of inflammation can remain higher compared to people who are not infected with HIV. Statins, such as pitavastatin, are medications that are used to lower the levels of cholesterol and triglycerides (fat in the blood) and have been shown to lower levels of inflammation and heart disease.
      • HIV infected men and women between the ages of 40 and 75
      • On anti-HIV medications for at least 6 months
      • CD4 cell count greater than 100
      • No history of cardiovascular disease, such as heart attack, stroke, etc.
      • No history of cancer in the last 3 years
      • Not currently using a statin drug
      Taiwo, Babafemi OTaiwo, Babafemi O
      NCT02344290 STU00200323
      More Info
      Copy
      A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults
      ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir in adult patients ho…
      ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir in adult patients hospitalized with COVID-19 and requiring supplemental oxygen administered by low flow, high flow, or non-invasive mechanical ventilation. 

      Hospitalized adults (>18 years) with symptoms suggestive of COVID-19

      Illness of any duration and laboratory-confirmed SARS-CoV-2 infection within 14 days

      Requires low or high flow oxygen devices or non-invasive mechanical ventilation

      Has not received 5 or more doses of remdesivir as treatment for COVID-19

      Has not receive 6mg or more of dexamethasone in one day, on more than one day in the past 7 days

      Taiwo, Babafemi OTaiwo, Babafemi O
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04280705 STU00212207
      More Info
      Copy
      ACTIV-2/A5401: Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID)

      ACTIV-2/A5401 is a master protocol to evaluate the safety and efficacy of investigational agents for the treatment of symptomatic non-hospitalized adults with COVID-19.

      This study is being done …

      ACTIV-2/A5401 is a master protocol to evaluate the safety and efficacy of investigational agents for the treatment of symptomatic non-hospitalized adults with COVID-19.

      This study is being done to rapidly and efficiently evaluate multiple potential therapeutics for COVID-19 in an outpatient setting.

      Duration of study: 28 days of intensive follow-up, followed by limited follow-up through 24 weeks.

      • Outpatient (non-hospitalized) adult (18 years or older)
      • Positive COVID-19 test within 10 days prior to Entry
      • Onset of at least one typical COVID-19 symptom no more than 10 days prior to Entry, plus one the following symptoms present within 24 hours of entry:

      –Fever or feeling feverish, cough, shortness of breath, sore throat, body or muscle pain, fatigue, headache,chills, nasal discharge or congestion, loss of taste or smell, nausea or vomiting, diarrhea

      Taiwo, Babafemi OTaiwo, Babafemi O
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04518410 STU00213144
      More Info
      COVID outpatient
      Copy
      A Multicenter Group to Study Acute Liver Failure. Long-term Outcomes of Acute Liver Failure Study Group Patients
      Data Registry study for acute liver failure.
      18-70 yr old adults. Acute Liver Failure (ALF) - INR > 1.5 and hepatic encephalopathy. Acute Liver Injury (ALI) - INR > 2, ALT > 10 x ULN
      Ganger, Daniel RGanger, Daniel R
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT00518440 STU00016475
      More Info
      Copy
      A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (LEGACY)
      A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderatel…
      A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (LEGACY)
      Hanauer, Stephen BHanauer, Stephen B
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT01848561 STU00094204
      More Info
      Copy
      Healthy Control Esophageal Registry and Biorepository
      This study is being done to compare how the esophagus and upper stomach work in people who have Scleroderma with symptoms of reflux disease or difficulty swallowing (dysphagia) to healthy controls. We will collect skin, esophageal and stomach biop…
      This study is being done to compare how the esophagus and upper stomach work in people who have Scleroderma with symptoms of reflux disease or difficulty swallowing (dysphagia) to healthy controls. We will collect skin, esophageal and stomach biopsies (small pieces of tissue) to be used for several studies.
      Must not be:
      - Obese (i.e. BMI ≥30)
      - Known medical illnesses that could affect esophageal function, gene expression or histology
      - Have a diagnosis of an eating disorder
      - Have a diagnosis of an autoimmune disease
      - A current or previous smoker (smoked >100 cigarettes in lifetime)
      - Have a history of alcohol abuse or addiction or score of 2 or higher on the CAGE questionnaire
      - Taking antacids and/or proton pump inhibitors for heartburn
      - Allergies to Fentanyl or Midolazam (sedatives used during endoscopy)
      - Allergies to Lidocaine (Lidocaine anesthetic jelly used during manometry).
      - Pregnant or nursing (hormones associated with pregnancy and lactation are known to affect esophageal function)
      Carlson, Dustin AllanCarlson, Dustin Allan
      • Map it 633 N. St. Clair St.
        Chicago, IL
      STU00096856
      More Info
      Copy
      A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Etrolizumab As An Induction And Maintenance Treatment For Patients With Moderately To Severely Active Crohn’s Disease (Protocol GA29144)
      A Phase III, Randomized, Double-Blind, Placebo…
      A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Etrolizumab As An Induction And Maintenance Treatment For Patients With Moderately To Severely Active Crohn’s Disease (Protocol GA29144)
      Hanauer, Stephen BHanauer, Stephen B
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT02394028 STU00201257
      More Info
      Copy
      An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn’s Disease Previously Enrolled In The Etrolizumab Phase III Protocol GA29144 (Protocol GA29145)
      An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active …
      An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn’s Disease Previously Enrolled In The Etrolizumab Phase III Protocol GA29144 (Protocol GA29145)
      Hanauer, Stephen BHanauer, Stephen B
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT02403323 STU00201259
      More Info
      Copy
      Semen quality in males with inflammatory bowel disease: Influence of medication for IBD
      Semen quality in males with inflammatory bowel disease: Influence of methotrexate, ustekinumab and tofacitinib treatment.
      • Map it 201 E. Huron St.
        Chicago, IL
      STU00201469
      More Info
      Copy
      Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease
      Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies…
      Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease
      Hanauer, Stephen BHanauer, Stephen B
      NCT02914561 STU00205056
      More Info
      Copy
      A PHASE 3 SINGLE CENTER STUDY OF ISLET TRANSPLANTATION IN NON-UREMIC DIABETIC PATIENTS
      Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determ…
      Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, specifically using Campath as induction, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.
      Borja-Cacho, DanielBorja-Cacho, Daniel
      NCT01897688 STU00059469
      More Info
      Copy
      Chronic Kidney Disease Research Biorepository
      The objective of this study is to create a biorepository of stored blood and urine specimens and demographic and clinical data collected from patients with chronic kidney disease and healthy volunteers for use in chronic kidney disease research
      Isakova, TamaraIsakova, Tamara
      • Map it 633 N. St. Clair St.
        Chicago , IL
      STU00201546
      More Info
      Copy
      Transformative Research In Diabetic Nephropathy (TRIDENT) (SP0043185)
      This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest b…
      This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest blood, urine and genetic materials to elucidate molecular pathways and link them to biomarkers that characterize those patients have a rapid decline in kidney function (> 5 mL/min/1.73m2/year) from those with lesser degrees of kidney function change over the period of observation. High through-put genomic analysis associated with genetic and biomarker testing will serve to identify key potential therapeutic targets for DKD by comparing patients with rapid and slow progression patterns. Each participating clinical site will search for, consent, harvest the biopsy sample, and enroll the participants as required for the TRIDENT protocol.
      Inclusion Criteria
      • Type 1 and 2 Diabetes by ADA criteria (see appendix )
      • Willingness to comply with study requirements, including intention to fully participate in protocol-specified follow-up at a clinical study site
      • Able to provide informed consent
      • Adult participants (no age restriction)
      • Planned medically indicated kidney biopsy, prescribed by a practicing nephrologist
      Exclusion Criteria
      • ESRD, defined as chronic dialysis or kidney transplant
      • History of receiving dialysis for more than 30 days
      • Institutionalized
      • Solid organ or bone marrow transplant recipient at time of first kidney biopsy
      • Less than 3-year life expectancy
      • Known alcohol or substance abuse
      • Unable to provide informed consent
      • No evidence of active cancer other than non-melanoma skin cancer
      Isakova, TamaraIsakova, Tamara
      • Map it 633 N. St. Clair St.
        Chicago , IL
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT02986984 STU00204808
      More Info
      Copy
      A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy
      (ACTIVE, NOT RECRUITING) C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in th…
      (ACTIVE, NOT RECRUITING) C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD) and C3 glomerulonephritis (C3GN). There is no approved treatment for patients with C3G. This is a randomized, double blind, placebo controlled Phase 2 study to evaluate the safety and efficacy of avacopan (CCX168) in patients with C3G. The primary objective is to evaluate the efficacy of avacopan compared to placebo based on histologic changes in kidney biopsies taken before and during treatment.
      Inclusion Criteria:
      1. Biopsy-proven C3G, either DDD or C3GN, with or without a renal transplant, within 12 weeks prior to screening or during screening:
      2. Male or female subjects, aged at least 18 years
      3. Female subjects of childbearing potential may participate if adequate contraception is used during, and for at least the three months after study completion; Male subjects with partners of childbearing potential may participate in the study if they had a vasectomy at least 6 months prior to randomization or if adequate contraception is used during, and for at least the 3 months after study completion;
      4. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol
      5. Judged to be otherwise fit for the study by the Investigator, based on medical history, physical examination, and clinical laboratory assessments.
      Exclusion Criteria:
      1. Pregnant or nursing;
      2. Secondary C3 disease
      3. History or presence of any form of cancer within the 5 years prior to screening,
      4. Currently on dialysis or will require dialysis wtihin 7 days of screening
      5. Positive hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) viral screening test indicative of acute or chronic infection;
      6. Evidence of tuberculosis
      7. Evidence of liver disease
      Ghossein, CybeleGhossein, Cybele
      NCT03301467 STU00206182
      More Info
      Copy
      Evaluation of Renal Microvascular Perfusion by Contrast Enhanced Ultrasound

      Contrast Enhanced Ultrasound Study:

      • The study’s purpose is to measure blood flow to and from the kidney via contrast-enhanced ultrasound (contrast agent, Lumason®, is given via IV administration)

      Contrast Enhanced Ultrasound Study:

      • The study’s purpose is to measure blood flow to and from the kidney via contrast-enhanced ultrasound (contrast agent, Lumason®, is given via IV administration)
      • Participation consists of 5 study visits that are spread out over the course of 24 months (Healthy and ESRD participants only complete the first 2 study visits)
      • Study procedures consist of measuring height, weight, and vital signs, answering questions about demographics and medical history, a blood draw and urine collection at every visit, and undergoing the contrast-enhanced ultrasound (only at visit 2)
      INCLUSION CRITERIA:
      • ≥ 18 years of age
      • Patient is able to provide written informed consent
      • Meet criteria for one of following patient populations:
      • CKD
      • eGFR ≥30 and <90 ml/min/1.73m2 by CKD Epidemiology Collaboration (CKD EPI) equation17 (with or without history of hypertension)
      AND
      • Urine albumin to creatinine ratio (UACR) ≥ 30mg/g creatinine
      OR
      • eGFR <30 ml/min/1.73m2 by CKD Epidemiology Collaboration (CKD EPI) equation (with or without history of hypertension AND with no UACR requirement)
      • ESRD
      • Currently receiving dialysis (hemodialysis or peritoneal dialysis)
      • No eGFR or UACR requirement
      • Healthy volunteer
      • No prior history of kidney disease (as defined by eGFR >60 ml/min/1.73m2 by CKD Epidemiology Collaboration (CKD EPI) equation and UACR <30 mg/g creatinine, based on Screening Visit lab results or average between local lab results (collected within 3 months from the date of the Screening Visit) and lab results from Screening Visit.
      • No self-reported history of hypertension, diabetes mellitus, liver disease, or cardiovascular disease

      • CKD-Biopsy
      • eGFR <90 ml/min/1.73m2 by CKD EPI equation
      OR
      • Urine albumin to creatinine ratio (UACR) ≥30 mg/g creatinine
      AND
      • Undergoing a clinically indicated renal biopsy
      • Transplant Kidney Biopsy
      • Kidney transplant recipient undergoing a protocol surveillance transplant kidney biopsy

      EXCLUSION CRITERIA:

      • Known hypersensitivity to sulfur hexafluoride lipid or to any component of Lumason®
      • Known severe pulmonary hypertension (pulmonary artery pressure > 75mmHg)
      • Active cardiac disease including any of the following:
      • Unstable angina
      • Myocardial infarction within 48 hours prior to date of proposed Lumason® administration
      • Severe arrhythmia (ventricular tachycardia, uncontrolled atrial fibrillation with rapid ventricular response, torsades de pointes)
      • Escalating vasopressor requirements in prior 24 hours
      • Recent neurological compromise (i.e. cerebrovascular accident including transient ischemic attacks within 3 months of Lumason® administration)
      • Emergency cardiac surgery
      • BMI ≥ 35 kg/m2
      • Clinical signs of acute rejection as the indication for transplant kidney biopsy
      • Inability for patient or patient’s surrogate to provide informed consent
      • Pregnancy
      • Incarcerated individuals

      Srivastava, AnandSrivastava, Anand
      • Map it 633 N. St. Clair St.
        Chicago , IL
      • Map it 201 E. Huron St.
        Chicago, IL
      STU00206894
      More Info
      Copy
      A Randomized, Multicenter, Double-Blind, Parallel, Active-Control Study of the Effects of Sparsentan, A Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis
      (ACTIVE, NOT RECRUITING) This is a randomized, multicen…
      (ACTIVE, NOT RECRUITING) This is a randomized, multicenter, double-blind, parallel, active-control study. The investigational drug (sparsentan) is a dual acting angiotensin receptor blocker and endothelin receptor agonist. The active control is irbesartan. Patients who meet eligibility criteria will require wash out from renin-angiotensin-aldosterone system (RAAS) blockers, if applicable prior to their first dose of study drug. Patients will be randomly assigned in a 1:1 ratio to receive either sparsentan or active control (irbesartan). 
      Inclusion Criteria:
      1. Primary FSGS
      2. Male or Female aged 18-75 years
      3. Urine protein/creatinine ratio ≥ 1.5 g/g
      4. Estimated glomerular filtration rate (eGFR) ≥ 30
      5. Blood pressure criteria:  ≥100/60 mmHg and ≤160/100 mmHg
      6. Women of child bearing potential must agree to the simulataneous use of 2 medically accepted methods of contraception from randomization until 90 days after the last dose of study medication. Males, unless surgically sterile, must agree to use highly reliable methods of contraception from randomization until 90 days after the last dose of study medication.
      Exclusion Criteria:
      1. Secondary FSGS
      2. History of type 1 diabetes, uncontrolled type 2 diabetes, organ transplantation, heart failure (Class II-IV), malignancy, significant valvular disease, or alcohol/substance abuse.
      3. History of significant cerebrovascular disease and/or coronary artery disease within 6 months
      4. Body Mass Index (BMI) > 40
      3. Females who are pregnant, plan to become pregnant through the course of the study, or are breastfeeding. Males who plan to father a child during the course of the study.
      Ghossein, CybeleGhossein, Cybele
      NCT03493685 STU00206193
      More Info
      Copy
      EMPA-KIDNEY Trial - A multicentre international randomized parallel group double-blind placebocontrolled clinical trial of EMPAgliflozin once daily to assess cardio-renal outcomes in patients with chronic KIDNEY disease
      EMPA-KIDNEY is a clinical trial evaluating the effects of empagliflozin on cardio…
      EMPA-KIDNEY is a clinical trial evaluating the effects of empagliflozin on cardiovascular health and progression of chronic kidney disease. This research is studying patients with chronic kidney disease (both with and without diabetes). The study involves taking the study medication every day for about 3-4 years. Additionally, the study team will ask participants to come for study visits, with 3 visits in the first 6 months and then one visit every 6 months until the end of the study. Visits will include surveys, blood and urine collection, and distribution of study medication.
      Age is ≥ 18 years at Screening;

      There is evidence of chronic kidney disease at risk of kidney disease progression;

      A local Investigator judges that the participant neither requires empagliflozin (or any other SGLT-2 or SGLT -1/2 inhibitor), nor that such treatment is inappropriate;

      none of the exclusion criteria apply

      Isakova, TamaraIsakova, Tamara
      • Map it 633 N. St. Clair St.
        Chicago , IL
      NCT03594110 STU00208411
      More Info
      Copy
      A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy At Risk Of Progressing to End-Stage Renal Disease (NefIgArd)

      The overall aim of this phase III, randomized, double-blind,placebo-controlled study is to evaluate …

      The overall aim of this phase III, randomized, double-blind,placebo-controlled study is to evaluate the efficacy, safety, and tolerabilityof Nefecon 16 mg per day in the treatment of patients with primaryImmunoglobulin A nephropathy at risk of progressing to end-stage renal diseasedespite maximum tolerated treatment with renin-angiotensin system blockadeusing angiotensin converting enzyme inhibitors or angiotensin II type Ireceptor blockers. The study will consist of 2 parts. Part A will includea 9 month blinded Treatment Period, and a 3-month Follow up Period. Part B willconsist of an observational Long-term Follow up Period in which the patientswill be followed until 100 clinical events, measured as reduction in eGFRcompared to baseline.

      Inclusion Criteria:

    • Female or male patients ≥18 years
    • Biopsy-verified IgA nephropathy
    • Stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or Maximum Tolerated Dose (MTD) according to the 2012 KDIGO (Kidney Disease: Improving Global Outcomes) guidelines
    • Urine protein creatinine ratio ≥1 g/24hr
    • eGFR ≥45 mL/min per 1.73 m2 and ≤90 mL/min per 1.73 m2 using the Chronic Kidney Diseae Epidemiology Collaboration (CKD-EPI) formula
    • Willing and able to give informed consent
    • Exclusion Criteria:

    • Systemic diseases that may cause mesangial IgA deposition.
    • Patients who have undergone a kidney transplant.
    • Patients with acute or chronic infectious disease including hepatitis, tuberculosis, human immunodeficiency virus (HIV), and chronic urinary tract infections.
    • Patients with liver cirrhosis, as assessed by the Investigator.
    • Patients with a diagnosis of type 1 or type 2 diabetes mellitus which is poorly controlled.
    • Patients with history of unstable angina, class III or IV congestive heart failure, and/or clinically significant arrhythmia, as judged by the Investigator;
    • Patients with unacceptable blood pressure control defined as a blood pressure consistently above national guidelines for proteinuric renal disease, as assessed by the Investigator
    • Patients with diagnosed malignancy within the past 5 years.
    • Wadhwani, ShikhaWadhwani, Shikha
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03643965 STU00207093
      More Info
      Copy
      A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 with Background Treatment in Subjects with Lupus Nephritis
      The "Paisley" study for Lupus Nephritis is a research study that is evaluating an oral investigational drug for people with moderate t…
      The "Paisley" study for Lupus Nephritis is a research study that is evaluating an oral investigational drug for people with moderate to severe lupus nephritis. 

      Inclusion Criteria:

      • Meets the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE and diagnosed ≥ 24 weeks before the screening visit
      • One of the following: antinuclear antibody (ANA) ≥ 1:80 or positive anti-double-stranded DNA (dsDNA) or positive anti-Smith (Sm)
      • Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI-2K score ≥ 4 points

      Exclusion Criteria:

      • Subjects with drug-induced SLE, certain other autoimmune diseases, and active, severe lupus nephritis
      • SLE overlap syndromes such as scleroderma and mixed connective tissue disease
      • Clinically significant abnormalities on chest x-ray or ECG
      • History of any significant drug allergy

      Other protocol defined inclusion/exclusion criteria could apply

      Wadhwani, ShikhaWadhwani, Shikha
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03943147 STU00210122
      More Info
      Copy
      Immune checkpoint inhibitor-associated acute kidney injury
      Since 2011, six immune checkpoint inhibitors (ICIs), a type of immunotherapy, have been approved by the Federal Drug Administration for use in patients with cancer.  These medications have been demonstrated to have great promise for trea…
      Since 2011, six immune checkpoint inhibitors (ICIs), a type of immunotherapy, have been approved by the Federal Drug Administration for use in patients with cancer.  These medications have been demonstrated to have great promise for treating a variety of cancers.  However, there are toxicities associated with these agents, known as immune-related adverse events (AKI), some of which can be fatal.  Affected organs include the skin (rash), gastrointestinal tract(diarrhea), and the kidneys (acute kidney injury [AKI]). This study, led by Drs. Shruti Gupta and David Leaf at Brigham and Women’s Hospital, has the goal of collecting data on over 300 ICI-associated acute kidney injury cases from more than 30 academic medical centers worldwide.  We will characterize the clinical features of ICI-associated AKI in the hope that this will help us to determine predictors  of toxicity and best practices for management. 
      Aggarwal, VikramAggarwal, Vikram
      STU00212602
      More Info
      Copy
      Northwestern Scleroderma Program Patient Registry
      The Scleroderma Patient Registry collects clinical information and biological samples for patients seen at the Northwestern Scleroderma Program (NSP). The information collected is used for studies designed to increase our understanding about the cours…
      The Scleroderma Patient Registry collects clinical information and biological samples for patients seen at the Northwestern Scleroderma Program (NSP). The information collected is used for studies designed to increase our understanding about the course of the disease and the care and outcomes of scleroderma patients. Researchers conduct studies to learn more about scleroderma, understand why the skin and other internal organs become thickened and hardened (fibrotic) in people with scleroderma, and determine what therapies are effective for treating scleroderma. The registry also allows us to identify possible patients for future studies related to scleroderma. There are five optional components of the Registry: completion of health questionnaires, skin biopsies at two different time points, annual blood collection, and participation in NUgene.
      Patients ≥18 years old with a diagnosis of scleroderma (including all sub-types of disease) as defined by American College of Rheumatology criteria or scleroderma mimic disorder, localized scleroderma, or very early diagnosis of systemic sclerosis (VEDOSS), per physician assessment.
      Correia, Chase StephenCorreia, Chase Stephen
      • Map it 633 N. St. Clair St.
        Chicago, IL
      STU00002669
      More Info
      Copy
      Chicago Lupus Database
      Establishing in 1991 and maintained by Northwestern University, the Chicago Lupus Database (CLD) is a registry of individuals with lupus who are willing to be contacted about future lupus research studies for which they might be eligible. Participants can enroll in any number …
      Establishing in 1991 and maintained by Northwestern University, the Chicago Lupus Database (CLD) is a registry of individuals with lupus who are willing to be contacted about future lupus research studies for which they might be eligible. Participants can enroll in any number of research studies designed to help us learn more about lupus.
      Men and women 18 years or older with either a probable or definite lupus diagnosis can sign up for the Chicago Lupus Database.
      Ramsey-Goldman, RosalindRamsey-Goldman, Rosalind
      • Map it 633 N. St. Clair St.
        Chicago, IL
      STU00009193
      More Info
      lupus
      Copy
      Genome Research in African American Scleroderma Patients (GRASP)
      Previous scleroderma studies have found that the risk of developing scleroderma is higher among African Americans than in Caucasians. The purpose of this study is to determine how variations in genes (or inherited traits) may explain t…
      Previous scleroderma studies have found that the risk of developing scleroderma is higher among African Americans than in Caucasians. The purpose of this study is to determine how variations in genes (or inherited traits) may explain the different risk in developing scleroderma seen in African American patients compared to other populations. Participants will complete a brief health questionnaire and provide two tubes of blood.
      African American patients who are evaluated at the Northwestern Scleroderma Program and meet criteria for the diagnosis of systemic sclerosis, Age ≥ 18 years old
      Correia, Chase StephenCorreia, Chase Stephen
      • Map it 633 N. St. Clair St.
        Chicago, IL
      STU00069421
      More Info
      Copy
      The Scleroderma Patient-Centered Intervention Network (SPIN) Cohort
      The Scleroderma Patient-Centered Intervention Network (SPIN) is an organization that was established by researchers, health care providers, and people living with scleroderma from Canada, the USA, and Europe. The objectives of SPIN a…
      The Scleroderma Patient-Centered Intervention Network (SPIN) is an organization that was established by researchers, health care providers, and people living with scleroderma from Canada, the USA, and Europe. The objectives of SPIN are: 1. To learn more about important problems faced by people living with scleroderma (e.g., fatigue, emotional distress, physical limitations). 2. To develop and test internet-based interventions to support people in their efforts to cope with living with scleroderma. Participants will be asked to complete quality of life questionnaires via the internet every 3 months.
      Diagnosis of scleroderma. Fluent in English. Must have access to the Internet to complete questionnaires.
      Correia, Chase StephenCorreia, Chase Stephen
      • Map it 633 N. St. Clair St.
        Chicago, IL
      STU00092924
      More Info
      Copy
      Synovial Macrophage Transcriptional Signatures for Predicting Therapeutic Efficacy
      We know that in rheumatoid arthritis (RA), considerable thickening of the lining layer (synovium) in the joints occurs. This represents the accumulation of new cells and tissue. We would like to learn more about what c…
      We know that in rheumatoid arthritis (RA), considerable thickening of the lining layer (synovium) in the joints occurs. This represents the accumulation of new cells and tissue. We would like to learn more about what contributes to the disease progression of RA and why some people respond to RA therapy, while others do not. To do this, we will examine the cells, genetic material, proteins and other features in the tissue from the inflamed joints and blood of patients with RA. We hope that by studying this tissue and blood, we may learn information that may help lead to the development of new treatments for this disease.
      • Diagnosis of rheumatoid arthritis (RA).
      • Must have been 18 years of age or older at the time of diagnosis of RA.
      • At least one swollen joint (elbow, writs, knee, ankle, or shoulder) due to active RA.
      Perlman, Harris RPerlman, Harris R
      • Map it 633 N. St. Clair St.
        Chicago, IL
      STU00104822
      More Info
      Copy
      SPARC: Gene expression profiling in scleroderma to discover therapeutic targets and predict clinical course
      The purpose of this study is to identify and validate a molecular classification of scleroderma that will allow us to predict which patients will develop specific complications and to match tar…
      The purpose of this study is to identify and validate a molecular classification of scleroderma that will allow us to predict which patients will develop specific complications and to match targeted treatments to the appropriate patients. The study will also focus on identifying inflammatory and fibrotic molecular pathways that are important in the disease Participants will be asked to give: - Two punch skin biopsies from the forearm (size of a pencil eraser) - Two tubes of blood - Urine collection Participants will be paid $110 for the one-time study visit. We are recruiting both patients with scleroderma and healthy control subjects.
      Participants must be: Over age 18, No chronic skin conditions, No rheumatic autoimmune diagnosis (e.g., lupus, rheumatoid arthritis, scleroderma), Not currently pregnant.
      Varga, JohnVarga, John
      • Map it 633 N. St. Clair St.
        Chicago, IL
      STU00200631
      More Info
      Copy
      LIFT: Lupus Intervention for Fatigue Trial
      This study is designed to evaluate the effectiveness of one-on-one counseling sessions on reducing symptoms of fatigue in persons with lupus by providing them with individualized coaching on increasing physical activity and improving diet.
      Have lupus and experience fatigue as a result.

      At least 18 years old.

      Can participate in physical activity.

      Live in the Chicago area.

      Be able to speak and read English.

      Be able to consent to being in the study.

      Ramsey-Goldman, RosalindRamsey-Goldman, Rosalind
      • Map it 633 N. St. Clair St.
        Chicago, IL
      NCT02653287 STU00201960
      More Info
      Copy
      Vasculitis Clinical Research Consortium (VCRC) Genetic Repository One Time DNA Protocol
      The study is being done to identify genes that increase the risk of developing vasculitis. The purpose of the study is to: Collect clinical data and genetic information (DNA) on patients with vasculitis; Discover…
      The study is being done to identify genes that increase the risk of developing vasculitis. The purpose of the study is to: Collect clinical data and genetic information (DNA) on patients with vasculitis; Discover genetic markers that increase the risk of developing vasculitis; Discover genetic markers linked with certain symptoms of vasculitis. The study involves donating two tubes of blood for the collection of genetic information (DNA) at one study visit.
      - Giant Cell Arteritis
      - Takayasu’s Arteritis
      - Polyarteritis Nodosa
      - Granulomatosis with Polyangiitis (Wegener’s)
      - Microscopic Polyangiitis
      - Eosinophilic granulomatosis with polyangiitis (Churg-Strauss)
      Dua, Anisha BharadwajDua, Anisha Bharadwaj
      • Map it 633 N. St. Clair St.
        Chicago , IL
      STU00206908
      More Info
      Copy
      xIRB A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis
      Subjects will be randomized to receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day in a 2:1:2 ratio. The length of …
      Subjects will be randomized to receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day in a 2:1:2 ratio. The length of study participation is about one year.
      Subjects must meet criteria for dermatomyositis and have active disease based on physician assessment.  Subjects can be on immunosuppressant medications for DM while in the study, but must be on a stable dose for 8 weeks at the screening visit.  If subject is on corticosteroids (≤ 20 mg), they must be on a stable dose at least 4 weeks at the time of study enrollment.  Subjects cannot have unstable dermatomyositis or end stage organ involvement.
      Hsieh, ChristineHsieh, Christine
      • Map it 633 N. St. Clair St.
        Chicago, IL
      NCT03813160 STU00209094
      More Info
      Copy