CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled / 30 target
Drug / intervention
romidepsin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02232516
NCT02232516Phase 2CompletedUpdate Overdue (0.2/mo)Completion was 70mo ago
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Phase II Study of Romidepsin Plus Lenalidomide for Patients With Previously Untreated PTCL

Northwestern University·interventional·Posted Sep 5, 2014·Updated Jun 12, 2026

In Brief

A Phase 2 clinical trial evaluating romidepsin, lenalidomide, and 1 other intervention for Adult Nasal Type Extranodal NK/T-cell Lymphoma and 16 related conditions. Completed, enrolled 30 participants across 5 sites.

Signals

Enrollment appears stalled

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Hepatosplenic T-cell Lymphoma, Peripheral T-cell Lymphoma, Stage I Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IA Mycosis Fungoides/Sezary Syndrome, Stage IB Mycosis Fungoides/Sezary Syndrome, Stage II Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IIA Mycosis Fungoides/Sezary Syndrome, Stage IIB Mycosis Fungoides/Sezary Syndrome, Stage III Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IIIA Mycosis Fungoides/Sezary Syndrome, Stage IIIB Mycosis Fungoides/Sezary Syndrome, Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IVA Mycosis Fungoides/Sezary Syndrome, Stage IVB Mycosis Fungoides/Sezary Syndrome
CountriesUnited States
CollaboratorsCelgene, National Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 5, 2014
Enrollment StartJun 11, 2015
Primary CompletionAug 11, 2020
Study CompletionMar 16, 2024
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 11.8 years ago

Arms & Interventions

Treatment (romidepsin, lenalidomide)experimental

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.

Drug: romidepsinDrug: lenalidomideOther: laboratory biomarker analysis

Interventions

romidepsindrug

Given IV

lenalidomidedrug

Given PO

laboratory biomarker analysisother

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