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Northwestern University Feinberg School of Medicine
Department of Medicine
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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
Screening For a Registry (Database) and Future Participation In Asthma and Chronic Obstructive Lung Disease (COPD) Clinical Research Studies
Recent advances in understanding asthma and COPD have led to the development of several new forms of treatment. After these new treatments are evaluated in la…
Recent advances in understanding asthma and COPD have led to the development of several new forms of treatment. After these new treatments are evaluated in laboratory studies, the most promising ones are tested in human subjects. At the same time, research is being done on cells and secretions obtained from normal individuals and patients with asthma and COPD to increase our understanding of what causes these diseases and to determine how they can best be treated. You are being asked to take part in an evaluation of your health status in order to determine your eligibility to participate in future clinical research studies. The evaluation will involve assessing your overall medical condition and the status of your asthma, if you have asthma or the status of your COPD, if you have COPD. The evaluation will help determine if you may be eligible for current or future asthma and COPD clinical research studies done at Northwestern University.
18 years of age or older with asthma or COPD(Chronic Obstructive Lung Disease)
Kalhan, RaviKalhan, Ravi
  • Map it 201 E. Huron St.
    Chicago, IL
STU00015972
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Hixon, Jenny Lorraine 312 926 0975
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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
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Hixon, Jenny Lorraine 312 926 0975
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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
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Hixon, Jenny Lorraine 312 926 0975
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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
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Hixon, Jenny Lorraine +1 312 926 0975
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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
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Goldberg, Isaac +1 312 503 2157
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A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study Of Benralizumab in Patients with Severe Nasal Polyposis (OSTRO)
AstraZeneca is doing this research to find out if an experimental medication called benralizumab could be effective and safe a…
AstraZeneca is doing this research to find out if an experimental medication called benralizumab could be effective and safe and used to treat severe nasal polyposis. Benralizumab is an antibody made in the laboratory that has been made to block the effect of IL-5 at the eosinophil. Antibodies are proteins naturally produced by your body that find foreign substances such as bacteria, fungi, viruses and other substances that enter your body and make them inactive. Benralizumab may help decrease swelling in the air passages of people with nasal polyps.
In order to qualify for the study you must have a total polyp score of at least 5.
Peters, Anju TripathiPeters, Anju Tripathi
NCT03401229 STU00206667
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Hadzic, Amela 312 695 3530
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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
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Dvorak, Stephen 312 695 4481
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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 Chris ChrisMalaisrie, S Chris Chris
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03003299 STU00204739
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Kats, Lauren 312 926 1096
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EFFECTS OF DAPAGLIFLOZIN ON BIOMARKERS, SYMPTOMS AND FUNCTIONAL STATUS IN PATIENTS WITH PRESERVED EJECTION FRACTION HEART FAILURE (PRESERVED-HF TRIAL)
This study is recruiting people who have Type 2 diabetes mellitus (T2DM) or prediabetes and heart failure (Inability of the heart to pump blood with …
This study is recruiting people who have Type 2 diabetes mellitus (T2DM) or prediabetes and heart failure (Inability of the heart to pump blood with normal efficiency). The purpose of the study is to find out if a drug called dapagliflozin would be effective in improving the blood tests and symptoms related to heart failure while also treating type 2 diabetes or potentially preventing type 2 diabetes if you have pre-diabetes. To do this, dapagliflozin will be compared with placebo. The placebo will look like dapagliflozin but is inactive. Dapagliflozin lowers glucose (sugar) levels in the blood by blocking the effect of specific molecules (small particles) called sodium-glucose transporters. Under normal circumstances, the sodium-glucose transporters in the kidney prevent glucose in the blood stream from leaving the body through urine. Dapagliflozin inhibits the sodium-glucose transporters and lowers blood glucose by allowing glucose removal through the urine. Dapagliflozin may also mildly decrease body weight and lower blood pressure in certain patients. Dapagliflozin is approved by the United States Food and Drug Administration (FDA) for the treatment of type 2 diabetes. Dapagliflozin is not specifically approved for the treatment of type 2 diabetes in people with heart failure and therefore its use in this study is investigational. We expect up to 20 people here will be in this research study out of 320 people in the entire study nationally..

  • Age > 18 and < 120 at the screening visit
  • Symptoms of dyspnea (NYHA class II-IV) without evidence of a non-cardiac or ischemic explanation for dyspnea
  • Ejection fraction (EF) ≥ 45% as determined on imaging study within 24 months of enrolment with no change in clinical status suggesting potential for deterioration in systolic function
  • Elevated NT-proBNP (≥ 225 pg/ml) or BNP (≥ 75 pg/ml)
  • Stable medical therapy for heart failure for 15 days as defined by: i. No addition or removal of ACE, angiotensin receptor blockers (ARBs), valsartan/sacubitril, beta-blockers, calcium channel blockers (CCBs) or aldosterone antagonists ii. No substantial change in dosage (100% or greater increase or decrease from baseline dose) of ACE, ARBs, beta-blockers, CCBs or aldosterone antagonists
  • On a diuretic ≥15 days prior to screening visit and a stable diuretic therapy for 7 days

Khan, SadiyaKhan, Sadiya
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03030235 STU00204842
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Roshevsky, Daniel Scott 312 695 3264
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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
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Kats, Lauren 312 926 1096
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REDUCE LAP-HF RANDOMIZED TRIAL II: A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure
The purpose of this study is to evaluate the safety and effectiveness of an investigational device for heart failure symptoms. Invest…
The purpose of this study is to evaluate the safety and effectiveness of an investigational device for heart failure symptoms. Investigational means it has not been approved by the USA Food and Drug Administration (FDA).The device is called the IASD System II, which is an “inter-atrial shunt”. The device is permanently implanted into the heart. It is designed to reduce the pressure in a part of the heart called the left atrium. This is done by creating a small opening between the left atrium and the right atrium of your heart. If it lowers the pressure in your heart at rest or during activity, it may lessen some of the symptoms you have. You have a 50% chance of receiving the device and a 50% chance of being in the control group for 2 years and then you may have the option of receiving the device This study is an FDA approved clinical trial for this device. The FDA will review the safety results and the treatment effect found in this study. If the FDA accepts the research results the FDA can approve the device for sale in the USA. In April 2016, the Study Device received CE Marking, which is an approval that allows it to be sold in the European Union. If you agree to participate in this study, we expect that you will be involved for about five (5) years. Being in this study requires regular doctor visits. There are visits for testing before the procedure. After the procedure, there are visits at 1 month, 3 months, 6 months and 12 months, and then yearly visits until 5 years after the procedure. The study is over when all the subjects have had their last doctor visit. We expect up to 12 people here will be in this research study out of 700 people in the entire study internationally
INCLUSION CRITERIA:

  • Chronic symptomatic heart failure (HF) documented by the following:
    • Symptoms of HF requiring current treatment with diuretics for ≥ 30 days
    • New York Heart Association (NYHA) class II with a prior history of > NYHA class II; NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening visit; or signs (any rales post cough, chest x-ray demonstrating pulmonary congestion,) within past 12 months; AND
    • ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV), or intensification of oral diuresis for HF in a healthcare facility (emergency department/acute care facility), within the 12 months prior to study entry; OR an NT-pro BNP value > 150 pg./ml in normal sinus rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months.
  • 2.Ongoing stable GDMT HF management and management of potential comorbidities according to the 2013 ACCF/AHA Guidelines for the management of Heart Failure, with no significant changes (>100% increase or 50% decrease), excluding diuretic dose changes, for a minimum of 4 weeks prior to screening which is expected to be maintained for 6 months.
  • 3.Age ≥ 40 years old
  • 4.Site determined echocardiographic LV ejection fraction ≥40% within the past 6 months,without documented ejection fraction <30% in the 5 years prior to study entry.
EXCLUSION CRITERIA

  • MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization; AVR (surgical AVR or TAVR) within the past 12 months.
  • Cardiac resynchronization therapy initiated within the past 6 months
  • Advanced heart failure defined as one or more of the below:
    • a.ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
    • b.Cardiac index < 2.0 L/min/m2
    • c.Inotropic infusion (continuous or intermittent) for EF < 40% within the past 6 months
    • d.Patient is on the cardiac transplant waiting list4.Inability to perform 6 minute walk test (distance < 50 m), OR 6 minute walk test > 600m
  • 5.The patient has verified that the ability to walk 6 minutes is limited primarily by joint, foot, leg, hip or back pain; unsteadiness or dizziness or lifestyle and not by shortness of breath and/or fatigue and/or chest pain.

Flaherty, James DFlaherty, James D
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03088033 STU00204899
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Roshevsky, Daniel Scott 312 695 3264
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Assessment of the WATCHMAN(TM) Device in Patients Unsuitable for Oral Anticoagulation
This study will evaluate the safety and effectiveness of the WATCHMAN Device in patients who cannot use oral anticoagulation (OAC) therapy (blood thinner medication). Participants in this study will be assigned by c…
This study will evaluate the safety and effectiveness of the WATCHMAN Device in patients who cannot use oral anticoagulation (OAC) therapy (blood thinner medication). Participants in this study will be assigned by chance (“randomized”) to one of two groups: the Device Group or the Control Group. There will be two people assigned to the Device Group for every one person assigned to the Control Group. Participants in the Device Group will be scheduled for WATCHMAN Device implantation. Participants the Control Group will not have the device implanted and will be prescribed single antiplatelet therapy or no therapy for the duration of the trial at the discretion of the study physician. In this study, the WATCHMAN Device itself and the implantation procedure are the same as the FDA approved WATCHMAN. The only difference is that no OAC therapy will be administered after implant. Therefore, the use of the WATCHMAN Device in this study is considered “investigational” because it has not been approved by the FDA for use without short-term OAC therapy. Participants in this study will be in this research study for about 5 years. During this time, participants will be asked to come to clinic for 6-7 study visits, and the study team will contact participants by telephone for 5 phone “visits”. We expect up to 70 people here will be in this research study out of 888 people in the entire study internationally.
Inclusion Criteria:
Documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation. The subject has a calculated CHA2DS2-VASc score of 2 or greater.
Deemed by two study physicians to be unsuitable for oral anticoagulation.
Deemed by a study physician to be suitable for the defined protocol pharmacologic regimen of aspirin and clopidogrel therapy following WATCHMAN Closure Device implant.
Able and willing to return for required follow-up visits and examinations.

Exclusion Criteria:
The subject had or is planning to have any invasive cardiac procedure within 30 days prior to randomization (e.g., cardioversion, ablation).
Planning to have any cardiac or non-cardiac invasive or surgical procedure that would necessitate stopping or modifying the protocol required medication regimen within 90 days after the WATCHMAN Closure Device implant (e.g., cardioversion, ablation, cataract surgery).
Prior stroke (of any cause) or TIA within the 30 days prior to randomization.
Prior bleeding event within the 14 days prior to randomization.
History of atrial septal repair or has an ASD/PFO device.
An implanted mechanical valve prosthesis in any position.
The subject suffers from New York Heart Association Class IV Congestive Heart Failure.
The subject has LVEF < 30%.
Knight, Bradley PaulKnight, Bradley Paul
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02928497 STU00205007
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Carswell, Amy 312 926 7554
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Real Life Multimarker Monitoring in Patients with Heart Failure (REALIsM-HF)

The study aims to explore two marketed devices, monitoring physical activity under real-life conditions in patients with HFpEF and HFrEF.

Furthermore, it aims to address the challenges and feasibility of implementi…

The study aims to explore two marketed devices, monitoring physical activity under real-life conditions in patients with HFpEF and HFrEF.

Furthermore, it aims to address the challenges and feasibility of implementing device based measurements under real-life conditions.

Female and male subjects with a diagnosis of acute decompensated heart failure with preserved ejection fraction (HFpEF; EF ≥ 45%) or

acute decompensated heart failure with reduced ejection fraction (HFrEF; EF ≤ 35%) will be enrolled.

Shah, Sanjiv JShah, Sanjiv J
  • Map it 201 E. Huron St.
    Chicago, IL
STU00206315
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Ramirez, Haydee +1 312 695 2928
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Microtubule Polymerization of Modulators for Treating LMNA-Related Dilated Cardiomyopathy
This study is enrolling patients diagnosed with LMNA-related dilated cardiomyopathy (DCM), who have an irregular heart rhythm (arrhythmia) or their heart is not working properly (myocardial dysfunction). For thi…
This study is enrolling patients diagnosed with LMNA-related dilated cardiomyopathy (DCM), who have an irregular heart rhythm (arrhythmia) or their heart is not working properly (myocardial dysfunction). For this study, we are evaluating use of a medication, colchicine, to see if it can help improve heart function and reduce irregular heart rhythms in patients with LMNA related DCM
1. Confirmed diagnoses of LMNA cardiomyopathy (confirmed with genetic testing). 2. Evidence of myocardial dysfunction OR cardiac arrhythmia
Wilcox, Jane ElizabethWilcox, Jane Elizabeth
  • Map it 201 E. Huron St.
    Chicago, IL
STU00206184
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Roshevsky, Daniel Scott 312 695 3264
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Dilated Cardiomyopathy (DCM) Research Project
Dilated cardiomyopathy (DCM) is a condition in which the heart becomes enlarged and the heart muscle weakened, causing the heart to pump blood less efficiently. DCM is commonly caused by heart muscle damage (“a heart attack”) from coronary artery di…
Dilated cardiomyopathy (DCM) is a condition in which the heart becomes enlarged and the heart muscle weakened, causing the heart to pump blood less efficiently. DCM is commonly caused by heart muscle damage (“a heart attack”) from coronary artery disease. Other causes include exposure to some drugs, such as cancer chemotherapy. When the cause is unknown, it is called idiopathic DCM. Among individuals with idiopathic DCM, having relatives undergo a cardiac check-up (echocardiogram, ECG) will reveal familial DCM in up to one-third of cases. A high level of suspicion of familial DCM is also raised when family members have had heart failure, a heart transplant, sudden death (without a history of coronary artery disease), or arrhythmias, which sometimes require a pacemaker or defibrillator. WHAT DOES THIS STUDY INVOLVE? IF YOU HAVE IDIOPATHIC DCM: Participation involves inviting all your first-degree relatives (children, parents, siblings) with or without heart disease. If you have other more distant relatives with DCM, they are also welcome to participate. To help with this process, we provide a letter that you can share with your relatives, and a family history questionnaire for you to complete. You may also receive a communication tool to help you invite your family members to the study. Your participation also involves providing cardiovascular information and medical records, completing annual surveys, and a blood draw. FOR FAMILY MEMBERS: Participation of family members involves collecting cardiac information and a blood draw. To better understand the genetic cause of DCM, it is helpful to compare results from family members with and without the condition. Because DCM can be present but silent for years, it is difficult to know with certainty if a family member does or does not have DCM unless a cardiac check-up is performed. Medical guidelines recommend this for 1st degree family members of individuals with DCM. Therefore, we also ask family members who enroll to obtain cardiac screening with both an echocardiogram and an electrocardiogram (ECG) if they have not done so recently.
Inclusion Criteria:

Meeting criteria for dilated cardiomyopathy (DCM) :
Left ventricular ejection fraction 95%tile population standard based on gender and height).
Detectable causes of cardiomyopathy, except genetic, excluded beyond a reasonable doubt at the time of DCM diagnosis (that is, meeting clinical criteria for idiopathic DCM)
Any age (including children)
Non-Hispanic and Hispanic ethnicity
All races (PI pre-approval required for recruitment beyond pre-specified recruitment targets).
Ability to give informed consent
Ability to communicate in English (except Spanish language at sites approved to recruit individuals of Hispanic ethnicity)
Willingness to participate in a family-based study (patient willing to work with a clinical site and/or OSU to facilitate the recruitment and enrollment of family members to the study).

Exclusion Criteria:

Coronary artery disease (CAD) causing ischemic cardiomyopathy (> 50% narrowing, any major epicardial coronary artery)
Primary valvular disease
Adriamycin or other cardiotoxic drug exposure
Other forms of cardiomyopathy: Hypertrophic, Restrictive, or Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy
Congenital heart disease
Other detectable causes of dilated cardiomyopathy, including sarcoid and hemochromatosis.
Other active multi-system disease that may cause DCM (e.g., active connective tissue disease).
Severe and untreated or untreatable hypertension (systolic blood pressures routinely greater than 180 mm Hg and/or diastolic blood pressures greater than 120 mm Hg, and if resistant to multidrug treatment).
However, conventional risk factors for DCM, including obesity, routinely treated hypertension, alcohol use, pregnancy or the peri-partum period, or left ventricular noncompaction, will NOT be considered exclusion criteria.
Wilcox, Jane ElizabethWilcox, Jane Elizabeth
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03037632 STU00205850
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Whisler, Cailin 312 926 3356
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Edwards Cardioband™ Tricuspid Valve Reconstruction System Early Feasibility Study
This study is recruiting patients with tricuspid regurgitation (a condition in which blood flow through the tricuspid valve of the heart flows in the wrong direction) that may benefit from a new tricuspid valve recons…
This study is recruiting patients with tricuspid regurgitation (a condition in which blood flow through the tricuspid valve of the heart flows in the wrong direction) that may benefit from a new tricuspid valve reconstruction system. This is an early feasibility clinical research study that will evaluate the safety and performance of the Edwards Cardioband Tricuspid Valve Reconstruction System, (the “Study Device” ). The Study Device includes an adjustable implant that is delivered and anchored to the tricuspid valve by a transfemoral delivery system, meaning it is inserted in a minimally invasive procedure through a puncture into a vein in the leg. The Cardioband Implant will be positioned around the tricuspid valve and will be adjusted to reduce the size of the valve, thus improving the tricuspid regurgitation. Up to 15 patients will be enrolled in this study at up to 15 sites. All enrolled study patients will be assessed at the following intervals: screening/baseline, procedure, discharge, 1 month, 6 months, 1 year and annually for 5 years post implant procedure.
Davidson, Charles JDavidson, Charles J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03382457 STU00207338
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McCloskey, Elizabeth 312 926 0840
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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
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Whisler, Cailin +1 312 926 3356
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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
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    Kats, Lauren +1 312 926 1096
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    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
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    Kats, Lauren 312 926 1096
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    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Cardiomyopathy (ATTRIBUTE-CM Trial)
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Sym…
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Cardiomyopathy (ATTRIBUTE-CM Trial)
    • Have an established diagnosis of ATTR-CM with either wild-type TTR or a variant TTR genotype
    • Have:
      • history of heart failure evidenced by at least one prior hospitalization for heart failure or
      • clinical evidence of heart failure without prior heart failure hospitalization manifested by signs or symptoms of volume overload or elevated intracardiac pressures (e.g., elevated jugular venous pressure, shortness of breath or signs of pulmonary congestion on x-ray or auscultation, or peripheral edema) or
      • heart failure symptoms that required or require ongoing treatment with a diuretic
    Shah, Sanjiv JShah, Sanjiv J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03860935 STU00209465
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    Medina, Frank 312 926 8629
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    Percutaneous or Surgical Mitral Valve REpair in PAtients with PrImaRy MItral Regurgitation who are Candidates for Surgery (REPAIR-MR)

    The purpose of this researchstudy is to compare health outcomes of patients diagnosed with Primary MR whohave their MV repaired with open heart surgery, which is th…

    The purpose of this researchstudy is to compare health outcomes of patients diagnosed with Primary MR whohave their MV repaired with open heart surgery, which is the current standardtreatment, to patients who have their Mitral Valve repaired with the MitraClipSystem. The MitraClip System uses a less invasive procedure to repair themitral valve.

    Subjects are asked to participatein this Study because they have moderate-to-severe or severe MR and it has beendetermined to have symptoms due to heart failure despite being treated with currentlyavailable therapies. MR occurs when the leaflets of your mitral valve do notclose properly causing blood to leak backward with each heartbeat. Since someof the blood leaks backward, the heart needs to pump more blood with each beatto push the same amount of blood forward.

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

    • Subject hassevere (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
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    Kats, Lauren +1 312 926 1096
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    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 andeffectiveness of an investigational tricuspid valve repair system, calledTriClipTM Device, which i…
    The purpose of this research study is to compare the safety andeffectiveness of an investigational tricuspid valve repair system, calledTriClipTM Device, which is inserted into the heart, along with usingoptimal 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 beenrolled 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 tricuspidregurgitation determined to have symptoms due to heartfailure despite being treated with currently available therapies

    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03904147 STU00210487
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    1-855-NU-STUDY
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    A randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study to investigate the efficacy and safety of finerenone, in addition to standard of care, on the progression of kidney disease in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease
    The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.
    • Subjects with type 2 diabetes mellitus
    • Subjects with a clinical diagnosis of diabetic nephropathy (DN) based on the following criteria: Persistent very high albuminuria defined as urinary albumin-to-creatinine ratio (ACR) of > 300 mg/g in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) 25 - < 75 mL/min/1.73 m² Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB), but not both, for at least 3 months
    • Serum potassium
    Huang, WenyuHuang, Wenyu
    NCT02540993 STU00201605
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    Adelman, Daphne T 312 908 9002
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    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
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    1-855-NU-STUDY
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    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
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    Hakamy, Beth +1 312 503 7203
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    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
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    1-855-NU-STUDY
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    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 McGrae DouglasMcDermott, Mary McGrae Douglas
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02538900 STU00105855
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    Domanchuk, Kathryn J 312 503 6438
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    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 McGrae DouglasMcDermott, Mary McGrae Douglas
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02593110 STU00200954
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    Domanchuk, Kathryn J 312 503 6438
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    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
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    Seltzer, Anne Jennifer 312 926 5159
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    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 McGrae DouglasMcDermott, Mary McGrae Douglas
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02676466 STU00201974
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    Domanchuk, Kathryn J 312 503 6438
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    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 McGrae DouglasMcDermott, Mary McGrae Douglas
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02876887 STU00202741
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    Domanchuk, Kathryn J 312 503 6438
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    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
    STU00204308
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    Serrano, Eloisa +1 312 503 6501
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    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
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    Study Coordinator 312 695 1102
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    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
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    Study Coordinator 312 695 1102
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    NU 1365-001: A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma
    Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be…
    Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery.

    This phase II trial is studying how well radiolabeled glass beads work in treating patients with liver cancer that cannot be removed by surgery.

    You may be eligible for this research study if you have unresectable cancer primarily in the liver (with the liver being the only site of disease or the dominant site of disease).
    Salem, RiadSalem, Riad
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT00530010 STU00011036
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    Study Coordinator 1 312 695 1102
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    A Humanitarian Device Exemption Compassionate Use Protocol of TheraSphere for Treatment of Unresectable Metastatic Cancer to the Liver

    Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells m…

    Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery.

    This phase II trial is studying how well radiolabeled glass beads work in treating patients with metastatic liver cancer that cannot be removed by surgery.

    You may be eligible for this research study if you have been diagnosed with metastatic disease to the liver. This means your cancer originated from somewhere else in your body and spread to your liver.

    You cannot be eligible to have surgery to remove the cancerous tissue from your liver.

    Salem, RiadSalem, Riad
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT00532740 STU00011037
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    Study Coordinator 312 695 1102
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    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
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    Study Coordinator 312 695 1102
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    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
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    Study Coordinator 312 695 1102
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    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, PriyaKumthekar, Priya
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00087359
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    Study Coordinator 1 312 695 1102
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    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, NishaMohindra, Nisha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02201992 STU00102000
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    Study Coordinator 312 695 1102
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    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, NishaMohindra, Nisha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02194738 STU00200150
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    Study Coordinator 312 695 1102
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    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
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    Study Coordinator 312 695 1102
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    ECOG-ACRIN 1131: A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients with Residual Triple-Negative Breast Cancer following Neoadjuvant Chemotherapy

    The main purpose of this study is to compare getting more treatment with capecitabine (i.e. on…

    The main purpose of this study is to compare getting more treatment with capecitabine (i.e. one of the usual approaches), to getting more treatment with a platinum-based chemotherapy (using the drug cisplatin or carboplatin), after surgery.

    Platinum agents (cisplatin or carboplatin) are already FDA-approved to be used in patients with stage IV (i.e., metastatic) breast cancers, but are usually not used in patients with early forms of breast cancer. Getting a platinum-based chemotherapy after surgery could reduce the risk of cancer returning (metastatic recurrence) in the breast or at other distant organs, but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than using capecitabine chemotherapy.

    You may be eligible for this research study if you:

    • Have early stage breast cancer.
    • Have a breast cancer that does not have the estrogen, progesterone or HER2 receptor, and is called triple-negative breast cancer.
    • Have completed all your chemotherapy prior to your surgery.
    • Had ≥ 1 cm worth of cancer in the breast at the time of your surgery.

    Flaum, LisaFlaum, Lisa
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02445391 STU00201173
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    Study Coordinator 312 695 1102
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    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
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    Study Coordinator 312 695 1102
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    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
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    Study Coordinator 312 695 1102
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    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
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    Study Coordinator 312 695 1102
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    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, PriyaKumthekar, Priya
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02523014 STU00202953
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    Study Coordinator 312 695 1102
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    NRG-GY006: A Randomized phase III trial of radiation therapy and cisplatin alone or in combination with intravenous triapine in women with newly diagnosed bulky stage IB2, or stage II, IIIB, or IVA cancer of the uterine cervix or stage II-IVA vaginal cancer.

    The purpose of this study is to compare…

    The purpose of this study is to compare the effects of adding triapine to the usual cisplatin chemotherapy and radiation therapy, as compared to using cisplatin chemotherapy and radiation therapy alone. Triapine is an experimental drug being tested in the treatment of cervical cancer to improve the effects of standard radiotherapy with concurrent chemotherapy. The addition of triapine to the usual chemotherapy and radiation therapy could shrink your tumor and increase the length of time till the cancer returns, but it could also cause side effects. This study will allow the researchers to know whether this new approach is better, the same, or worse than the usual approach.

    You may be eligible for this research study if you have newly diagnosed cervical or vaginal cancer for which surgical treatment is not possible.

    Donnelly, EricDonnelly, Eric
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02466971 STU00203105
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    Study Coordinator 312 695 1102
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    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
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    Study Coordinator 312 695 1102
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    DRUG CC-90009-AML-001: A PHASE 1, OPEN-LABEL, DOSE-FINDING STUDY OF CC-90009, A NOVEL CEREBLON E3 LIGASE MODULATING DRUG, IN SUBJECTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA OR RELAPSED OR REFRACTORY HIGHER-RISK MYELODYSPLASTIC SYNDROMES

    The purpose of this study is to test the safety (…

    The purpose of this study is to test the safety (any good or bad effects) of the new experimental drug, CC-90009 (study treatment), in subjects with relapsed or refractory acute myeloid leukemia (AML). The purpose is also to see if CC-90009 can control the disease and to explore how long CC-90009 stays in the body.

    CC-90009 has not been approved by the Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia or any other cancer or disease and its use in this study is investigational. This study is the first time CC-90009 is being given to humans.

    Laboratory and animal studies showed that CC-90009 can slow down the growth or kill cancer cells. CC-90009 binds to a protein called cereblon inside cells in your body, including the AML cells. Upon binding with CC-90009, cereblon causes the destruction of other proteins that the AML cells need for survival.

    This study also includes testing of blood and bone marrow aspirate samples for biomarkers. Biomarkers are substances such as proteins and genes that tell us how the drug is working in the body. These studies may help to better understand the genetic profile of AML as well as determine whether CC-90009 is having an effect on the cancer or in the blood.

    You may be eligible for this research study if you have been diagnosed with acute myeloid leukemia (AML) that has come back after treatment or cannot be cured or treated by any other known therapies.

    Altman, Jessica KAltman, Jessica K
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02848001 STU00203119
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    Study Coordinator 312 695 1102
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    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
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    Study Coordinator 312 695 1102
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    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
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    Study Coordinator 1 312 695 1102
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    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, JeffreySosman, Jeffrey
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00204151
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    Study Coordinator 1 312 695 1102
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    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
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    Study Coordinator 312 695 1102
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    BTCRC-GI15-015: A Phase II Study of FOLFOX combined with Nab-Paclitaxel (FOLFOX-A) in the Treatment of Metastatic or Advanced Unresectable Gastric, Gastro-Esophageal Junction Adenocarcinoma

    This study is being done to find out if a drug called nab-paclitaxel plus a combination chemotherapy regimen…

    This study is being done to find out if a drug called nab-paclitaxel plus a combination chemotherapy regimen called FOLFOX have any effect on stomach cancer or cancer where the esophagus and the stomach meet. The study drugs could shrink your cancer but it could also cause side effects.

    Nab-paclitaxel is a new formulation of a chemotherapy called paclitaxel. Regular paclitaxel is made with stabilizers that cause allergic reactions in many patients. Nab-paclitaxel does not use these stabilizers which means more of the drug can be given with fewer allergic reactions. Nab-paclitaxel (Abraxane®) is approved by the U.S. Food and Drug Administration (FDA) to treat breast, lung, and pancreas cancers.

    FOLFOX stands for a combination of three drugs: oxaliplatin, leucovorin, and 5-fluorouracil. Oxaliplatin is a chemotherapy approved by the FDA to treat colon and rectal cancer. Leucovorin is not a chemotherapy. It is form of folic acid and it is given with 5-fluorouracil to help increase the anti-cancer effects of 5-fluorouracil. It is approved by the FDA to be given with fluorouracil in patients with advanced colorectal cancer. 5-fluorouracil is approved by the FDA to treat cancers of the breast, stomach, colon, rectum, and pancreas.

    Combining nab-paclitaxel with FOLFOX should be considered investigational. Investigational means that the FDA has not approved this combination of drugs for stomach cancer or cancer where the esophagus and the stomach meet.

    Benson III, Al BBenson III, Al B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03283761 STU00205558
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    Study Coordinator 1 312 695 1102
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    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, JeffreySosman, Jeffrey
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03138512 STU00205491
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    Study Coordinator 312 695 1102
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    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
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    Study Coordinator 312 695 1102
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    A Phase 1b/2 Open-Label, Dose Escalation and Expansion Study of Orally Administered VRx-3996 and Valganciclovir in Subjects with Epstein-Barr Virus-Associated Lymphoid Malignancies

    This study tests the combination of an investigational drug, called VRx-3996, along with an antiviral (fights viruses…

    This study tests the combination of an investigational drug, called VRx-3996, along with an antiviral (fights viruses) drug called valganciclovir. “Investigational” means the drug being tested (VRx-3996) has not been approved by the United States Food and Drug Administration (FDA). The antiviral drug, valganciclovir, has been FDA-approved to prevent and treat certain types of viral infections. Some people may already have received or are currently taking the antiviral drug, valganciclovir, for their disease.

    The primary purpose of this study is to determine how safe is it to take the investigational drug (VRx-3996) along with valgaciclovir and find the maximal dose that can be taken safely. The study will also determine if the cancer responds to treatment with the drug combination. The study will also evaluate how much of the study drug is present in your blood at different time points.

    You may be eligible for this research study if you have a cancer, called lymphoma, that tested positive for Epstein-Barr Virus (EBV).

    Karmali, ReemKarmali, Reem
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT03397706 STU00206699
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    Study Coordinator 312 695 1102
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    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, AmiShah, Ami
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03147287 STU00207256
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    Study Coordinator 1 312 695 1102
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    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
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    Study Coordinator 312 695 1102
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    A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) plus Chemotherapy (XP or FP) versus Placebo plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects with Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585).
    The purpose of this s…
    The purpose of this study is to test the safety, efficacy, and tolerability of the research study drug, pembrolizumab (MK-3475) in combination with cisplatin and capecitabine or 5- fluorouracil (5-FU).

    You may be eligible for this research study if you have gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma.

    Benson III, Al BBenson III, Al B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03221426 STU00207611
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    Study Coordinator 1 312 695 1102
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    (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, ShiraDinner, Shira
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03150693 STU00208162
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    Study Coordinator 312 695 1102
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    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
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    Study Coordinator 312 695 1102
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    (xIRB NCI CIRB) Alliance A011401: Randomized Phase III Trial Evaluating The Role Of Weight Loss In Adjuvant Treatment Of Overweight And Obese Women With Early Breast Cancer
    This study is being done to see if losing weight may help prevent breast cancer from coming back. Previous studies have found th…
    This study is being done to see if losing weight may help prevent breast cancer from coming back. Previous studies have found that women who are overweight or obese when their breast cancer is found have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. At this time we do not know whether or not losing weight will reduce the risk of breast cancer returning. This study seeks to determine whether or not the higher risk for breast cancer recurrence in women who are overweight or obese when they are diagnosed with breast cancer could be reduced or eliminated if weight is lost. It is important to note that we do not know how much weight would need to be lost to lower the risk of breast cancer recurrence, or whether this strategy would work for all women. This study willhelp to show researchers whether weight loss programs should be a part of breast cancer treatment.

    This study seeks to determine whether or not the higher risk for breast cancer recurrence in women who are overweight or obese when they are diagnosed with breast cancer could be reduced or eliminated if weight is lost.

    Donnelly, EricDonnelly, Eric
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02750826 STU00208895
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    Study Coordinator 312 695 1102
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    (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, EricDonnelly, Eric
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03488693 STU00208897
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    Study Coordinator 1 312 695 1102
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    A Multicenter, Open-Label Phase 1b Study to Assess Safety and Efficacy of Venetoclax in Combination with Gilteritinib in Subjects with Relapsed/Refractory Acute Myeloid Leukemia

    The purpose of this study is to see if the study drugs, venetoclax and gilteritinib, can be safely and effectively combi…

    The purpose of this study is to see if the study drugs, venetoclax and gilteritinib, can be safely and effectively combined for the treatment of patients with acute myeloid leukemia (AML) that has returned after prior treatment or has failed to respond to prior treatment, and to identify potential biomarkers.

    Venetoclax has been approved by the United States Food and Drug Administration (FDA) and other health authorities to treat specific blood cancers. Gilteritinib has been approved by the FDA for the treatment of FLT3 mutation positive relapsed or refractory AML. However, the combination of venetoclax and gilteritinib has not been approved for treatment of AML; therefore, the use of these study drugs in combination is investigational (experimental) for the purposes of this study.

    This is the first study of venetoclax in combination with gilteritinib. Venetoclax in combination with gilteritinib may or may not work better than either drug alone.

    As part of this study, samples will be collected for biomarker research. The purpose of this biomarker research is:

    • To find out why some patients with the disease being studied respond better or worse to the study drug or drugs of the same or similar class;
    • To possibly find out how the disease being studied and related conditions develop and progress and how they can be diagnosed, monitored or treated;
    • To possibly develop tests to identify which patients are likely to have specific diseases, respond to the study drug or drugs of the same or similar class, or to predict the progression of the disease being studied;
    • To possibly develop new therapies, research methods or technologies.

    You may be eligible for this research study if you have been diagnosed withAcute Myeloid Leukemia (AML) that has returned after prior treatment (relapsed) or has failed torespond to prior treatment (refractory).
    Altman, Jessica KAltman, Jessica K
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03625505 STU00208729
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    Study Coordinator 312 695 1102
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    Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma

    The purpose of this study is to compare any good and bad effects of using different drugs in combination with an antibody. An antibody is a protein that can recognize and attack foreign objects (antigens) in the body. H…

    The purpose of this study is to compare any good and bad effects of using different drugs in combination with an antibody. An antibody is a protein that can recognize and attack foreign objects (antigens) in the body. Here, the antibody is obinutuzumab. It is looking for CD20, an antigen that is found on tumor cells. Two study drugs will be tested in this study: TGR-1202 and lenalidomide. Each of these study drugs may help the immune system fight cancer. During the study, you will get either obinutuzumab plus TGR-1202, obinutuzumab plus lenalidomide, or obinutuzumab plus the usual approach treatment for your cancer.

    The addition of TGR-1202 or lenalidomide could shrink your cancer, but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. The antibody (obinutuzumab) and the regular chemotherapy approach are FDA-approved for use in follicular lymphoma, but they aren’t usually used together. The immune system drug, TGR-1202, is not FDA approved. The immune system drug lenalidomide is FDA approved, but not for follicular lymphoma.

    Another purpose of this study is to test PET/CT scans, which are a way to take pictures of your type of cancer. The researchers want to use PET/CT scans to help diagnose and monitor your cancer. PET/CT scans are a part of regular care for your type of cancer. All of the patients taking part in this study will have PET/CT scans sent to a central PET/CT reviewer.

    Another purpose of this study is to see whether a set of gene mutations (called m7-FLIPI) can predict whether your lymphoma will respond better or worse to the study treatment. Mutations are permanent changes in your DNA. The researchers will look for the mutations on your tumor tissue and in tumor cells found in your blood. All of the patients taking part in this study will have blood and tissue submitted for these gene mutation tests.

    You may be eligible for this research study if you have follicular lymphoma that has either not responded to previous treatment or that has come back after previous treatment.

    Winter, Jane NormaWinter, Jane Norma
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03269669 STU00209296
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    Study Coordinator 312 695 1102
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    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
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    Study Coordinator 312 695 1102
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    A Phase II, Open-Label, Multicenter, Randomized Study Of The Efficacy And Safety Of RO7198457 In Combination With Pembrolizumab Versus Pembrolizumab In Patients With Previously Untreated Advanced Melanoma
    The purpose of this study is to compare the effects, good or bad, of PCV plus pembrolizumab vers…
    The purpose of this study is to compare the effects, good or bad, of PCV plus pembrolizumab versus pembrolizumab alone on patients with melanoma. In this study, particpants will get either PCV plus pembrolizumab or pembrolizumab alone.The goal of a PCV is to help train the immune system to recognize and attack cancer cells. And because the immune system has memory, it is hoped that once the immune cells have been trained, they will continue to work long after the vaccine is given. This treatment is a type of immunotherapy. To make PCV, samples of tumor tissue and blood will be collected and tested to see if a vaccine can be made for participants.Pembrolizumab is approved in the United States and the European Union, as well as other countries, for the treatment of unresectable or metastatic melanoma, and several other indications.PCV is an experimental drug, which means health authorities have not approved PCV in combination with pembrolizumab for the treatment of melanoma, and it has not been tested in people with untreated melanoma prior to this study.
    Participants must be age 18 years or older. Metastatic or unresectable locally advanced melanoma. 
    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03815058 STU00209868
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    Study Coordinator 312 695 1102
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    (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, ShiraDinner, Shira
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03504644 STU00210605
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    Study Coordinator 312 695 1102
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    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
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    Study Coordinator 312 695 1102
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    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.
    Matei, DanielaMatei, Daniela
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03016819 STU00210420
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    RTK inhibitor

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    Study Coordinator 312 695 1102
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    (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, AmiShah, Ami
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04001829 STU00210984
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    Study Coordinator 312 695 1102
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    (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
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB ETCTN 10107: Phase 1 Safety Run-In and Phase 2 Randomized Clinical Trial of Anetumab Ravtansine and MK-3475 (Pembrolizumab) Compared to MK-3475 (Pembrolizumab) Alone for Mesothelin-Positive Malignant Pleural Mesothelioma

    Phase 2:

    Participants withmalignant pleural mes…

    Phase 2:

    Participants withmalignant pleural mesothelioma which has grown or has returned after initialtreatment with chemotherapies, and tumor tissue that shows the expression of theprotein mesothelin to a certain degree will be enrolled into Phase 2 of thestudy.

    The purpose of Phase 2is to compare the effects, good and/or bad, of anetumab ravtansine when givenin combination with pembrolizumab to the use of pembrolizumab alone in patientshaving moderate or high levels of a protein called mesothelin in the tumorsample.

    This study will allow researchers to know whether this different approach is better, the same orworse than treatment with MK-3475 (pembrolizumab) alone. Another purpose ofthis study is for researchers to learn whether biomarker tests can help predictwhich patients may respond well to the study drugs. Anetumab ravtansine has notbeen approved by the FDA and is considered experimental.

    Group 1 will receiveMK-3475 (pembrolizumab), and Group 2 will receive anetumab ravtansine andMK-3475 (pembrolizumab).

    All participants willreceive the study drug(s) for up to a maximum of two years. After they finishtreatment with (MK-3475) pembrolizumab and anetumab ravtansine or pembrolizumabonly, their doctor will follow their condition every three months by telephonefor up to one year.

    participants 18 years or older who have malignant pleural mesothelioma which has grown or hasreturned after initial treatment with chemotherapies, and tumor tissue thatshows the expression of the protein mesothelin to a certain degree
    Mohindra, NishaMohindra, Nisha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03126630 STU00211023
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    Study Coordinator 312 695 1102
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    (xIRB) DRUG KRT-232-104: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined with Low-Dose Cytarabine (LDAC) or Decitabine in Patients with Acute Myeloid Leukemia (AML)

    Thisstudy will test an investigational drug called KRT-232 that has not be…

    Thisstudy will test an investigational drug called KRT-232 that has not beenapproved for the potential treatment of AML. This study will determine if thisdrug is able to reduce the growth of unhealthy or tumor cells, and help restorethe function of your bone marrow. The study drug will be given along withanother therapy for AML assigned by the study doctor. This other therapy will be either cytarabine(injected under the skin) or decitabine (injected into a vein).

    Thereare 2 parts planned for this study, Part A (Phase 1b) will test different dosesof KRT-232 given with either cytarabine or decitabine to identify therecommended dose for Part B. Part B (Phase 2) will continue to test thisKRT-232 recommended dose with either cytarabine or decitabine to determine ifit is a tolerable and effective treatment for AML.

    Participantsat our site will currently participate in only Part A.

    Participantswill take the study drug until their cancer becomes worse, have severe sideeffects, or the research study ends.

    • Participants must have been diagnosed with Acute Myeloid Leukemia (AML)
    • Participants must be 18 years of age or older
    Altman, Jessica KAltman, Jessica K
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04113616 STU00211193
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB ETCTN 10170: A Phase 2 Study of AZD1775 in SETD2-Deficient Advanced Solid Tumor Malignancies

    Participants who have a cancer which has grown or has recurred will be asked to participate in this study. The purpose of this study is to test any good and bad effects of the study drug ca…

    Participants who have a cancer which has grown or has recurred will be asked to participate in this study. The purpose of this study is to test any good and bad effects of the study drug called AZD1775 in tumors that have a mutation called SETD2. Researchers hope to learn if the study drug will shrink the cancer by at least one-quarter compared to its present size.

    All study participants will get the same study drug called AZD1775 until their disease gets worse, or the study drug causes side effects that cannot be managed with medications, or by changing the dose or schedule of the study drug.

    Participants ages 18 years of age or older who have a cancer that has grown or has recurred will be asked to participate in this study. 
    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03284385 STU00211328
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    Study Coordinator 312 695 1102
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    Drug Vedolizumab-3035: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vedolizumab in the Prophylaxis of Intestinal Acute Graft-Versus-Host Disease in Subjects Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
    The main purpose of th…
    The main purpose of this research study is to investigate the safety and effectiveness of Vedolizumab compared to placebo (dummy drug), for prevention of intestinal aGvHD in patients undergoing allo-HSCT from an unrelated donor for a hematologic malignancy, (cancers that affect the blood and/or lymphaticsystem).

    Some of the eligibility criteria include:

    • Participants must not have prior allo-Hematopoietic Stem Cell Transplantation (HSCT).
    • Participants must be 18 or older.
    Note: This is only a partial list of eligibilitycriteria. Please contact the Robert H. LurieComprehensive Cancer Center of Northwestern University for complete screeninginformation if you are interested in this clinical trial.
    Moreira, JonathanMoreira, Jonathan
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03657160 STU00210880
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    Study Coordinator 312 695 1102
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    (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, PriyaKumthekar, Priya
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04164901 STU00211620
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    Study Coordinator 312 695 1102
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    (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
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    Study Coordinator 312 695 1102
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    DRUG CA013-004: A Phase 1/2a Study of BMS-986179 Administered Alone and in Combination with Nivolumab (BMS-936558) in Subjects with Advanced Solid Tumors
    The purpose of the study is to test the safety and anti-tumor activity of a new drug called BMS-986179 (also known as anti-CD73) administered alone…
    The purpose of the study is to test the safety and anti-tumor activity of a new drug called BMS-986179 (also known as anti-CD73) administered alone and in combination with nivolumab (also known as BMS-936558).

    You may be eligible for this research study if you have an advanced solid tumor, renal cell cancer (RCC).

    Sosman, JeffreySosman, Jeffrey
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02754141 STU00211357
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    Study Coordinator 312 695 1102
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    (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
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    EPZ-6438

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    Study Coordinator 312 695 1102
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    (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
    STU00212482
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    Study Coordinator 312 695 1102
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    NU 19H11 - Identifying Molecular Markers That Predict Relapse After Therapy Discontinuation In Chronic Myeloid Leukemia

    Many patients with CML have long term “complete molecular” remissions with tyrosine kinase

    inhibitor drugs (such as imatinib or dasatinib). This refers to the inability…

    Many patients with CML have long term “complete molecular” remissions with tyrosine kinase

    inhibitor drugs (such as imatinib or dasatinib). This refers to the inability to detect any leukemia

    in the blood or bone marrow. Some patients with a complete molecular remission can stop

    treatment, but 50% of those who do will have their CML return within 2-3 years. We do not

    currently have a way to predict which patients will relapse (cancer returns) versus remain in

    sustained remission (all signs and symptoms of cancer have disappeared) after stopping

    therapy. The purpose of this study is to examine blood or bone marrow cells from patients with

    CML who are stopping treatment. By doing this study, we hope to identify characteristics of

    blood cells that predict the likelihood of relapse after stopping therapy.

    • 18-85 years of age
    • confirmed diagnosis of Chronic Myeloid Leukemia (CML) that meets the criteria for stopping therapy because of long term "complete molecular" remission
    • previous treatment with any tyrosine kinase inhibitor (TKI) drugs
    Eklund, Elizabeth AEklund, Elizabeth A
    • Map it 201 E. Huron St.
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    STU00212526
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    (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, ShiraDinner, Shira
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    NCT04313881 STU00212732
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    CCTG CE.7: A phase III trial of stereotactic radiosurgery compared with hippocampal-avoidant whole brain radiotherapy (ha-wbrt) plus memantine for 5-15 brain metastases

    This study is being done to answer the following question: Can we reduce your symptoms and lower the chance of the cancer growing…

    This study is being done to answer the following question: Can we reduce your symptoms and lower the chance of the cancer growing or getting worse by using stereotactic radiosurgery, compared to the usual radiotherapy? Stereotactic radiosurgery or SRS is a commonly used treatment for brain tumors. It is a one-day (or in some cases two day), out-patient procedure during which a high dose of radiation is delivered to small spots in the brain while excluding the surrounding normal brain.

    We are doing this study because we want to find out if this approach is better or worse than the usual approach for your type of cancer. The usual approach is defined as care most people get for cancer that has spread to the brain

    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.

    Kruser, TimothyKruser, Timothy
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03550391 STU00212914
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    (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, NishaMohindra, Nisha
    • Map it 201 E. Huron St.
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    NCT04092283 STU00212961
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    (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, AmiShah, Ami
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    NCT04316117 STU00213217
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    (xIRB) NCI CIRB ETCTN 10208: A Phase I Study of Anetumab Ravtansine in Combination with Either Anti-PD-1 Antibody, or Anti-CTLA4 and Anti-PD-1 Antibodies or Anti-PD-1 Antibody and Gemcitabine in Mesothelin-Positive Advanced Pancreatic Adenocarcinoma

    The purpose of this study is to test the …

    The purpose of this study is to test the safety of the drug combinations anetumab ravtansine and nivolumab

    (Group 1) or nivolumab and ipilimumab (Group 2) or gemcitabine and nivolumab (Group 3). This study

    tests different doses of the drug to see which dose is safer for people with pancreatic cancer who have

    received at least a systemic therapy, such as chemotherapy

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

    In the dose escalation part of this study, people with mesothelin positive pancreatic cancer will get different

    doses of the study drug depending on what group they are assigned to. This part of the study has three groups.

    •Group 1

    Participants in this group will get anetumab ravtansine with nivolumab.

    •Group 2

    Participants in this group will get anetumab ravtansine with nivolumab and Ipilimumab.

    •Group 3

    Participants in this group will get anetumab ravtansine with gemcitabine and nivolumab.

    Once the safer combination is determined in the dose escalation part of the study, the dose expansion part

    will open. This part of the study will have a lead-in phase of 1 week where participants receive either:

    -Anetumab ravtansine (Groups 1 or 2)

    -Anetumab ravtansine and gemcitabine (Group 3)

    In this part of this study, people with mesothelin positive pancreatic cancer will be placed into ONE

    of the following; Group 1, 2, or 3 depending on the finding observed in the dose-escalation.

    This will help study doctors to better understand the side effects that may occur with these drugs and evaluate the potential effect of the combination on pancreatic cancer.

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

    or until your cancer has progressed if you did not come off intervention for progression.

    This will be completed over the phone or in clinic every 8 weeks.

    Participants 18 years of age or older who have pancreatic adenocarcinoma that has spread outside of your pancreas, and you have already received a treatment considered effective for your disease but your cancer has now progressed.

    Kalyan, AparnaKalyan, Aparna
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    NCT03816358 STU00213324
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    (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.
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    STU00213326
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    mPCA

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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB ETCTN 10300: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1 (BLAST MRD AML-1): A Randomized Phase 2 Study of the Anti-PD-1 Antibody Pembrolizumab in Combination with Conventional Intensive Chemotherapy as Frontline Therapy in Patients with Acute Myeloid Leukemia

    The purpose of this study is to compare theusual treatment alone to adding immune system activating therapy, Pembrolizumab(MK-3475), to the usual treatment. This study will help the study doctors findout if this different approach is better than the usual approach. To decide if it is better, the study doctorswill be looking to see if the addition of pembrolizumab results in fewerdetectable leukemia using new methods.

    Pembrolizumab (MK-3475), is already approvedby the FDA for use in several cancers, including advanced or metastaticsmall-cell and non-small cell lung cancer, melanoma, head and neck cancer,urothelial cancer, hepatocellular carcinoma, gastric cancer, among others. However, Pembrolizumab (MK-3475) is notapproved by the FDA or known to be safe for use in AML either alone or incombination with standard chemotherapy.

    This study has 2 study groups. You will be putinto a group by chance. You will have anequal chance of being in Group 1 or Group 2

    Group 1

    Participants in group 1 will get the usualstudy drugs, cytarabine on Days 1-7 and either daunorubicin or idarubicin onDays 1-3. If you have evidence ofresidual leukemia in the bone marrow at Day 14, you will receive a second roundof the first part of therapy (5+2 chemotherapy), which means cytarabine on Days1-5 and either daunorubicin or idarubicin on Days 1-2. If you have a complete remission after thefirst part of therapy, you will continue with the second part of therapy thatconsists of up to four cycles of high dose cytarabine. If you remain in complete remission aftersecond part of therapy, you will be monitored without further therapy for up to3 years. If you proceed with atransplant, you will forgo any remaining protocol-defined therapy.

    Group 2

    Participants in group 2 will get the usualstudy drugs, cytarabine on Days 1-7 and either daunorubicin or idarubicin onDays 1-3. If you have evidence ofresidual leukemia in the bone marrow at Day 14, you will receive second dose ofthe first part of therapy (5+2 chemotherapy), which means cytarabine on Days1-5 and either daunorubicin or idarubicin on Days 1-2. Regardless of your bone marrow findings onDay 14, you will receive Pembrolizumab (MK-3475) IV on Day 8. If you have a complete remission after thefirst part of therapy, you will continue with the second part of therapy thatconsists of up to four cycles of high dose cytarabine with Pembrolizumab(MK-3475). If you remain in completeremission after the second part of therapy, you will be monitored withoutPembrolizumab (MK-3475) therapy on Day 1 of each 21-day cycle for up to 2years. If you proceed with a transplant,you will forgo any remaining protocol-defined therapy.

    Participants between the ages of 18 and 75 who have newly diagnosed AML willbe enrolled into this study.

    Dinner, ShiraDinner, Shira
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    STU00213544
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB ETCTN 10334: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2 (BLAST MRD AML-2): A Randomized Phase 2 Study of the Venetoclax, Azacitadine, and Pembrolizumab (VAP) Versus Venetoclax and Azacitadine as First Line Therapy in Older Patients with Acute Myeloid Leukemia (AML) Who Are Ineligible or Who Refuse Intensive Chemotherapy

    The purpose of this study is to compare the usual treatment alone to adding MK-3475 (pembrolizumab)

    to the usual treatment. 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 addition of pembrolizumab results in fewer detectable leukemia using new methods.

    MK-3475 (pembrolizumab), is already approved by the FDA for use in several cancers.

    However, MK-3475 (pembrolizumab) is not approved by the FDA or known to be safe for use in AML either alone or in combination with standard chemotherapy.

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

    Group 1

    Participants in this group will get the usual study drugs, azacitidine on Days 1-7 and

    venetoclax on Days 1-28 of the first cycle and on Days 1-21 or Days 1-28 of each cycle thereafter

    depending on the results of your blood count. If you are unable to receive azacitidine over

    the weekend, your doctor may give it to you for 5 days in week 1 and 2 days in week 2.

    If you derive a clinical benefit within the first 6 cycles of therapy, you will continue

    with the second part of therapy that consists of the same combination for up to 3 years

    provided you do not stop responding at any time during the second part of therapy.

    Group 2

    Participants in this group will get the usual study drugs, azacitidine on Days 1-7 and

    venetoclax on Days 1-28 of the first cycle and on Days 1-21 or Days 1-28 of each cycle thereafter

    depending on the results of your blood count. If you are unable to receive azacitidine over

    the weekend, your doctor may give it to you for 5 days in week 1 and 2 days in week 2.

    You will receive MK-3475 (pembrolizumab) on Day 8 of the first cycle and every 3 weeks thereafter.

    If you derive a clinical benefit within the first 6 cycles of therapy,

    you will continue with the second part of therapy that consists of the same combination

    for up to 3 years provided you do not stop responding.

    Participants ages 60 years or older who have newly diagnosed AML will be enrolled in this study. 
    Dinner, ShiraDinner, Shira
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    STU00213545
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    Study Coordinator 312 695 1102
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    (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.
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    STU00213585
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    Study Coordinator 312 695 1102
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    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.
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    NCT04417517 STU00213414
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    Study Coordinator 312 695 1102
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    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
    STU00213426
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    Study Coordinator 312 695 1102
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    A5320: Viral Hepatitis C Infection Long-term Cohort Study (V-HICS)
    This study will help to understand the impact of successful (sustained viral response, SVR) or unsuccessful hepatitis C treatment on a person’s health over many years. It will also help us understand how long resistance to new hepat…
    This study will help to understand the impact of successful (sustained viral response, SVR) or unsuccessful hepatitis C treatment on a person’s health over many years. It will also help us understand how long resistance to new hepatitis C medications lasts and whether it affects future hepatitis C treatments. This is an observational study and does NOT provide any Hepatitis C or HIV treatment.
    Persons who were treated with an oral direct acting anti-viral (DAA) therapy for hepatitis C, but did NOT have a successful response to treatment (non-SVR) (enrollment is closed to persons with successful response to treatment); Hepatitis C mono-infected OR Hepatitis C and HIV co-infected;
    Taiwo, Babafemi OTaiwo, Babafemi O
    STU00090304
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    Berzins, Baiba Ingrida 312 695 5012
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    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
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    Berzins, Baiba Ingrida 312 695 5012
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    ACTG A5354: Effect of Antiretroviral Treatment Initiated During Acute HIV-1 Infection on Measures of HIV-1 Persistence and on HIV-1-Specific Immune Responses
    This study will include people who have very recently been infected with HIV and will start them on anti-HIV (antiretroviral) drugs right away …
    This study will include people who have very recently been infected with HIV and will start them on anti-HIV (antiretroviral) drugs right away to see how this may change HIV’s impact on the body.
    • Men and women, at least 18 years old
    • Have certain lab tests done that confirm very early HIV infection (ie. before the blood shows that antibodies have been made, or just at the time antibodies are starting to be found in the blood)
    • Be willing to take drugs to treat HIV right away.
    Taiwo, Babafemi OTaiwo, Babafemi O
    NCT02859558 STU00203124
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    Berzins, Baiba Ingrida 312 695 5012
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    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 ofinvestigational agents for the treatment of symptomatic non-hospitalized adultswith COVID-19.

    This study is being done to…

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

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

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

    • Ambulatory (non-hospitalized) adult (18 years or older)
    • Active COVID-19 infection within 7 days prior to Entry
    • At least one typical COVID-19 symptom for within 10 days prior to Entry, plus one the following symptoms present within 48 hours of entry:

    –Fever or feeling feverish, cough, shortness of breath atrest or with activity, sore throat, body or muscle pain, fatigue, headache,chills

    Taiwo, Babafemi OTaiwo, Babafemi O
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04518410 STU00213144
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    COVID

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    Berzins, Baiba Ingrida +1 312 695 5012
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    A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19

    The AZD1222 COVID-19VACCINE Study is researching an investigational vaccin…

    The AZD1222 COVID-19VACCINE Study is researching an investigational vaccine for the prevention of COVID-19, the disease caused by the new coronavirus (SARS-CoV-2). The studywill see how safe the investigational vaccine is and how well it works.

    Participants will berandomly assigned (by chance) to receive 2 injections of either theinvestigational vaccine or placebo.

    If you take part, you willbe in the study for approximately 2 years and will require up to 10 visits toour study center. Additional visits may be required if you develop symptoms ofCOVID-19 during the study. Your health will be monitored carefully by a team ofdoctors and nurses throughout the study. The study injections, healthassessments, and medical tests related to the study will be provided at no costto you.

    You may be able to take part in the AZD1222 COVID-19 VACCINE Study if you:

    - Are 18 years of age or older

    - Are in good or stable health (you may have an underlying medical condition and still take part, if your disease is stable)

    - Have an increased risk of getting COVID-19

    - Do not have a previously confirmed diagnosis of COVID-19

    Taiwo, Babafemi OTaiwo, Babafemi O
    • Map it 676 N. Saint Clair St. Suite 940
      Chicago, IL
    STU00213385
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    COVID Vaccine

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    Berzins, Baiba Ingrida +1 312 695 5012
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    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
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    Gottstein, Jeanne H 312 694 0264
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    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, StephenHanauer, Stephen
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT01848561 STU00094204
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    Arrieta, Rose +1 312 695 5878
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    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, DustinCarlson, Dustin
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00096856
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    Masihi, Melina +1 312 695 0330
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    (xIRB) An Open-Label, Multicenter Study to Evaluate Long-term Outcomes with ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ II)
    The purpose of this study is to evaluate L…
    The purpose of this study is to evaluate Long-term Outcomes following treatment with ABT-450/r/ABT-267, ABT-333 with or without RBV in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
    Ganger, Daniel RGanger, Daniel R
    NCT02167945 STU00102262
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    1-855-NU-STUDY
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    A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis
    Primary Biliary Cirrhosis (PBC) is a serious, life--threatening, bile acid related liver disease …
    Primary Biliary Cirrhosis (PBC) is a serious, life--threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its hepatoprotective effects and result in attenuation of injury and improved liver function in a cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC patients.
    Flamm, Steven LFlamm, Steven L
    NCT02308111 STU00200837
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    Gottstein, Jeanne H 312 694 0264
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    An Open Label Extension And Safety Monitoring Study Of Moderate To Severe Ulcerative Colitis Patients Previously Enrolled In Etrolizumab Phase II/III Studies
    An Open Label Extension And Safety Monitoring Study Of Moderate To Severe Ulcerative Colitis Patients Previously Enrolled In Etrolizumab Phase …
    An Open Label Extension And Safety Monitoring Study Of Moderate To Severe Ulcerative Colitis Patients Previously Enrolled In Etrolizumab Phase II/III Studies
    Hanauer, StephenHanauer, Stephen
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02118584 STU00200583
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    Arrieta, Rose +1 312 695 5878
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    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, StephenHanauer, Stephen
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02394028 STU00201257
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    Arrieta, Rose +1 312 695 5878
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    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, StephenHanauer, Stephen
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02403323 STU00201259
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    Arrieta, Rose +1 312 695 5878
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    Phase III, Double Blind, Placebo Controlled, Multicenter Study Of The Efficacy And Safety Of Etrolizumab During Induction And Maintenance In Patients With Moderate To Severe Active Ulcerative Colitis Who Are Refractory To Or Intolerant Of Tnf Inhibitors (Protocol GA28950)
    Phase III, Double Blind, Pla…
    Phase III, Double Blind, Placebo Controlled, Multicenter Study Of The Efficacy And Safety Of Etrolizumab During Induction And Maintenance In Patients With Moderate To Severe Active Ulcerative Colitis Who Are Refractory To Or Intolerant Of Tnf Inhibitors (Protocol GA28950)
    Hanauer, StephenHanauer, Stephen
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02100696 STU00200704
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    Arrieta, Rose +1 312 695 5878
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    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.
    Bellaguarda, EmanuelleBellaguarda, Emanuelle
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00201469
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    Arrieta, Rose 312 695 5878
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    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, StephenHanauer, Stephen
    NCT02914561 STU00205056
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    Arrieta, Rose 312 695 5878
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    A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease
    A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of …
    A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease
    Hanauer, StephenHanauer, Stephen
    • Map it 259 E. Erie St. Sixteenth Floor
      Chicago, IL
    NCT03077412 STU00206753
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    Arrieta, Rose +1 312 695 5878
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    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
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    1-855-NU-STUDY
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    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
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    Martinez, Carlos 312 503 1808
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    A phase 3 randomized, open-label (sponsor-blind), active controlled, parallel-group, multi-center, event driven study in non-dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.
    This is a phase III study…
    This is a phase III study in non-dialysis subjects with anemia associated chronic kidney disease to evaluate the safety and efficacy of an investigational drug, Daprodustat when compared to darbepoetin alfa.
    Inclusion Criteria:1. Men or Women 18 to 99 years of age.2. Chronic Kidney Disease Stages 3, 4, or 53. Acceptable if on Erythropoietin-Stimulating Agents4. Hemoglobin between 8 to 12 g/dL5. Willingness to participate and capable of giving signed informed consent.Exclusion Criteria: 1. Currently receiving dialysis2. Planned kidney transplant within 1 year 3. Iron deficient4. Other causes of anemia (pernicious anemia, thalassemia major, sickle cell, myelodysplastic syndrome)5. Uncontrolled high blood pressure6. History of malignancy within 2 years 7. Unstable liver disease8. Chronic Class IV heart failure
    Ghossein, CybeleGhossein, Cybele
    • Map it 675 N. Saint Clair St. Seventeenth Floor, Suite 250
      Chicago, IL
    NCT02876835 STU00203935
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    Napoli, Sara 312 503 3865
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    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
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    Martinez, Carlos 312 503 1808
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    A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy
    C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two for…
    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
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    Napoli, Sara 312 503 3865
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    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
    This is a randomized, multicenter, double-blind, parallel, a…
    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
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    Napoli, Sara 312 503 3865
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    Protocol Dialysis Outcomes and Practice Patterns Study 2
    The Peritoneal Dialysis Outcomes and Practice Patterns Study 2 (PDOPPS 2) is a sociobehavioral research study seeking to identify and analyze the links between modifiable dialysis practices and health outcomes in patients receiving (or planning…
    The Peritoneal Dialysis Outcomes and Practice Patterns Study 2 (PDOPPS 2) is a sociobehavioral research study seeking to identify and analyze the links between modifiable dialysis practices and health outcomes in patients receiving (or planning to receive) chronic Peritoneal Dialysis (PD). The overarching goal of the study is to extend patient survival and improving quality of life for PD patients. There is no intervention being utilized as part of this research, participants will not incur charges as a result of study participation, and participants will not receive any financial compensation for participation in the study. Study participation consists of completing a patient questionnaire that asks about how kidney disease affects well-being and overall quality of life and extraction of data , by the study team, from a participant's medical record to complete other questionnaires associated with overall health. The duration of study participation is approximately 3 years and includes 4 study visits. The study visits consist of completing the an optional patient questionnaire on a yearly basis. The questionnaire will be completed when participants are seen in the dialysis clinic. Individuals can still choose to participate without having to complete the patient questionnaire.
    Inclusion Criteria
    • 18 years of age or older
    • Treated at a Peritoneal Dialysis facility
    • Receiving chronic, maintenance Peritoneal Dialysis provided by the facility but independent of the facility (for example., at home or a nursing home facility)
    • Incident patients must have initiated Peritoneal Dialysis within 60 days of the first Peritoneal Dialysis treatment at home/nursing home

    Exclusion Criteria
    • Less than 18 years of age
    • Receiving Peritoneal Dialysis for acute renal failure
    • Receiving concomitant Peritoneal Dialysis and Hemodialysis (hybrid therapy) *
    • Adults unable to consent/Cognitively impaired
    • Pregnant women
    • Prisoners or other detained individuals
    * Hybrid therapy will be excluded from sampling for incident patients only but will be included in prevalent patient sampling
    Isakova, TamaraIsakova, Tamara
    • Map it 633 N. St. Clair St.
      Chicago , IL
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00207081
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    Martinez, Carlos 312 503 1808
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    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
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    Martinez, Carlos +1 312 503 1808
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    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
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    Fox, Patrick +1 312 503 1887
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    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
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    Fox, Patrick +1 312 503 1887
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    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
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    Aggarwal, Vikram 1-855-NU-STUDY
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    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.
    Hinchcliff, Monique EHinchcliff, Monique E
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00002669
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    Carns, Mary 312 503 1137
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    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
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    lupus

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    Milaeger, Holly +1 312 503 0251
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    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, ChaseCorreia, Chase
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00069421
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    Carns, Mary 312 503 1137
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    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, ChaseCorreia, Chase
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00092924
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    Carns, Mary 312 503 1137
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    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
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    Carns, Mary 312 503 1137
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    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
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    Carns, Mary (312) 503 1137
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    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
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    Milaeger, Holly +1 312 503 3904
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    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, AnishaDua, Anisha
    • Map it 633 N. St. Clair St.
      Chicago , IL
    STU00206908
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    Carns, Mary 312 503 1137
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    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
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    Aren, Kathleen 312 503 1824
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