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Immunomodulatory Drug

Romidepsin + Lenalidomide for T-Cell Lymphoma

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

Approved for 10 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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 study objectives

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%

Diarrhea

14%

Anemia

14%

Vomiting

14%

Anorexia

14%

Thrombocytopenia

Dyspepsia

Soft tissue infection

Thrombosis

Pain

Hypotension

Hypertension

Nausea

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Romidepsin)

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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