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COMPLETED
NCT02232516
PHASE2

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

Sponsor: Northwestern University

View on ClinicalTrials.gov

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).

Official title: Phase II Study of Romidepsin Plus Lenalidomide for Patients With Previously Untreated PTCL

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2015-06-11

Completion Date

2024-03-16

Last Updated

2026-06-12

Healthy Volunteers

No

Interventions

DRUG

romidepsin

Given IV

DRUG

lenalidomide

Given PO

OTHER

laboratory biomarker analysis

Correlative studies

Locations (5)

City of Hope

Duarte, California, United States

Yale University

New Haven, Connecticut, United States

Northwestern University

Chicago, Illinois, United States

Weill Cornell Medicine

New York, New York, United States

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, United States