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ACTIVE NOT RECRUITING Phase 2

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

NCT02232516 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate how safe and effective the combination of the study drugs romidepsin and lenalidomide is for treating patients with peripheral t-cell lymphoma (PTCL) who have not been previously treated for this cancer. Currently, there is no standard treatment for patients with PTCL; the most common treatment used is a combination of drugs called CHOP, but this can be a difficult treatment to tolerate because of side effects, and is not particularly effective for most patients with PTCL. Romidepsin (Istodax®) is a type of drug called an HDAC inhibitor. It interacts with DNA (genetic material in cells) in ways that can stop tumors from growing. It is given as an infusion through the veins. Lenalidomide (Revlimid®) is a type of drug known as an immunomodulatory drug, or IMID for short. This drug affects how tumor cells grow and survive, including affecting blood vessel growth in tumors. It is given as an oral tablet (by mouth).

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG lenalidomide
  • DRUG romidepsin

Study Locations (5)

California

  • City of Hope — Duarte

Connecticut

  • Yale University — New Haven

Illinois

  • Northwestern University — Chicago

New York

  • Weill Cornell Medicine — New York

Washington

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2015-06-11
Est. Completion 2024-08
Phase Phase 2

Sponsor

Northwestern University

1,033 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02232516

The ClinicalTrials.gov registry entry for NCT02232516 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,033 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Anaplastic Large Cell Lymphoma appearing as the primary indexed condition, and to 3 interventions — of which laboratory biomarker analysis is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02232516 reports 5 study locations spanning 5 distinct geographic areas — top geographies include California, Connecticut, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02232516 about?

NCT02232516 is a clinical study titled "Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma". The purpose of this study is to evaluate how safe and effective the combination of the study drugs romidepsin and lenalidomide is for treating patients with peripheral t-cell lymphoma (PTCL) who have not been previously treated for this cancer. Currently, there is no standard treatment for patients ...

What is the current status of trial NCT02232516?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2015-06-11. Estimated completion is 2024-08.

What conditions does trial NCT02232516 study?

This clinical trial studies the following conditions: Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Peripheral T-cell Lymphoma, Adult Nasal Type Extranodal NK/T-cell Lymphoma, Hepatosplenic T-cell Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02232516?

The interventions under investigation include: laboratory biomarker analysis (OTHER), lenalidomide (DRUG), romidepsin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02232516?

This trial is sponsored by Northwestern University, which has 1,033 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02232516 being conducted?

This trial has 5 study locations across California, Connecticut, Illinois, New York, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial