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Immunomodulatory Drug

romidepsin for Peripheral T-Cell Lymphoma

Q: Where are patients being seen for this research?

<p>Weill Cornell Medicine in <a href="https://www.withpower.com/clinical-trials/new-york">New york</a>, New York, Fred Hutchinson <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Research Center/University of <a href="https://www.withpower.com/clinical-trials/washington">Washington</a> Cancer Consortium in Seattle, Washington, and Yale University in New Haven, <a href="https://www.withpower.com/clinical-trials/connecticut">Connecticut</a> are the primary locations for this trial with 5 other centres across the United States.</p>

Phase 2

Waitlist Available

Led By Jonathan Moreira, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up reported at 1 and 2 years after the start of treatment

Awards & highlights

Study Summary

This trial will test whether combining romidepsin and lenalidomide is a safe and effective treatment for PTCL.

Who is the study for?

Adults under 60 with untreated Peripheral T-Cell Lymphoma (PTCL) and specific blood counts, organ function, and performance status. Must agree to contraception use and pregnancy testing as per study requirements. Excludes those with certain other lymphomas, prior systemic PTCL therapy, recent chemotherapy or radiotherapy, HIV infection, pregnant/nursing women, heart conditions, psychiatric issues affecting compliance.Check my eligibility

What is being tested?

The trial tests the safety and effectiveness of romidepsin (an HDAC inhibitor given via infusion) combined with lenalidomide (an oral immunomodulatory drug), compared to standard treatments for PTCL. The goal is to find a more tolerable treatment option that could be more effective for patients.See study design

What are the potential side effects?

Potential side effects include reactions at the infusion site for romidepsin; fatigue; changes in blood counts leading to increased risk of infections or bleeding; digestive issues; and possible impact on liver function. Lenalidomide may cause birth defects if taken during pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ reported at 1 and 3 years after the start of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~reported at 1 and 3 years after the start of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and reported at 1 and 3 years after the start of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR), as Defined Per Cheson Criteria

Secondary outcome measures

Delay to Cytotoxic Chemotherapy

Duration of Response, Defined Per Cheson Criteria

Incidence of Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

+2 more

Other outcome measures

Immunohistochemistry Profile

NM PET/CT vs. CT Imaging in PTCL

Validate a New Prognostic Model for Newly Diagnosed PTCL

Side effects data

From 2012 Phase 2 trial • 14 Patients • NCT00084682

43%

Constipation

36%

Fatigue

21%

Lung infection

14%

Anorexia

14%

Vomiting

14%

Diarrhea

14%

Anemia

14%

Thrombocytopenia

Hypertension

Pain

Hypotension

Soft tissue infection

Thrombosis

Nausea

Dyspepsia

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Romidepsin)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (romidepsin, lenalidomide)Experimental Treatment3 Interventions

Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Romidepsin

FDA approved

Lenalidomide

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,585 Previous Clinical Trials

917,201 Total Patients Enrolled

CelgeneIndustry Sponsor

636 Previous Clinical Trials

128,941 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,637 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many patients are included in this research project?

"This trial is not admitting patients at the moment. The first posting was on June 1st, 2015 and there was an update on April 30th, 2021. However, if you are looking for other trials, 3237 studies related to lymphoma and 286 involving romidepsin are actively recruiting participants."

Answered by AI

What are the primary conditions that romidepsin has been shown to be effective against?

"Multiple myeloma is most commonly treated with romidepsin. Romidepsin is also effective at treating other conditions such as relapsed and/or refractory lymphoma, chronic lymphocytic leukemia, and at least two prior systemic chemotherapy regimens."

Answered by AI

Are there any other examples of romidepsin being used in medical research?

"Romidepsin was first studied at Saint Joseph Regional Medical Center-Mishawaka 16 years ago. So far, 1166 clinical trials have been completed with romidepsin. Now, there are 286 active clinical trials underway; a large number of these taking place in New york City."

Answered by AI

What are some of the risks associated with taking romidepsin?

"Romidepsin has received a score of 2 from our team at Power. This is because, although there is data suggesting that it is safe, there is no evidence yet to support its efficacy."

Answered by AI

Can new participants still join this research project?

"Currently, this study is not seeking new patients. However, it's worth noting that as of April 30th 2021, there were 3237 other clinical trials for lymphoma and 286 for romidepsin recruiting patients."

Answered by AI

Where are patients being seen for this research?

"Weill Cornell Medicine in New york, New York, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium in Seattle, Washington, and Yale University in New Haven, Connecticut are the primary locations for this trial with 5 other centres across the United States."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma

2015. "Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02232516.

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