Study on Pembrolizumab and Romidepsin for Treating Peripheral T-Cell Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT03278782

This clinical trial is testing the combination of pembrolizumab and romidepsin to see if it is safe and effective in treating peripheral T-cell lymphoma that has returned or not responded to previous treatments. Pembrolizumab may help the immune system attack cancer, while romidepsin may stop cancer cells from growing.

Patient Parameters

Parameter	Options

Program Overview

This study aims to evaluate the safety and effectiveness of combining pembrolizumab, an immunotherapy drug, with romidepsin, a drug that may block cancer cell growth, in treating peripheral T-cell lymphoma that has come back or is resistant to treatment. The trial will assess if this combination works better than pembrolizumab alone.

Description

The main goals of this study are to determine if the combination of pembrolizumab and romidepsin is safe and to estimate how well it works in treating peripheral T-cell lymphoma that has returned or is resistant to treatment. Researchers will also look at how long patients live without the disease getting worse, overall survival rates, and how long the treatment response lasts.

Participants will receive romidepsin through an IV on specific days of each treatment cycle and pembrolizumab through an IV on the first day of each cycle. Each cycle lasts 21 days, and treatment can continue for up to 36 cycles unless the disease progresses or side effects become unacceptable. After finishing the treatment, participants will have follow-up visits at 30 days and then every 12 weeks.

Eligibility Criteria

Inclusion Criteria

Diagnosed with peripheral T-cell lymphoma, including specific subtypes like PTCL-NOS and anaplastic large T-cell lymphoma.
The cancer must have returned or not responded after at least one previous treatment.
Patients can participate regardless of eligibility for stem cell transplant.
Must have measurable disease, with a tumor or mass at least 1.5 cm in size.
Must be 18 years or older and able to provide informed consent.
Must provide a recent tumor biopsy sample, if possible.
Must have good overall health with a performance status of 0, 1, or 2.
Must have adequate organ function based on specific lab tests.
Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and after the study.
Men must agree to use contraception during and after the study.
Patients with certain types of cutaneous T-cell lymphomas that have transformed and are aggressive may also be eligible.

Exclusion Criteria

Currently receiving or recently participated in another study with investigational treatment.
Have an immune deficiency or are taking high doses of steroids or other immunosuppressive drugs.
Have active tuberculosis or a history of severe allergic reactions to pembrolizumab.
Have had recent treatment with certain cancer therapies or have not recovered from previous treatments.
Have another active cancer requiring treatment within the last 3 years, with some exceptions.
Have active brain metastases or cancer in the brain lining.
Have active autoimmune disease requiring treatment in the past 2 years.
Have active lung inflammation or infection requiring treatment.
Have any condition that might interfere with the study or is not in the patient's best interest.
Have psychiatric or substance abuse issues affecting study participation.
Are pregnant, breastfeeding, or planning to have children during the study.
Have received prior therapy with certain immune checkpoint inhibitors.
Have a history of HIV or active hepatitis B or C.
Have certain heart conditions or are taking specific medications that affect the heart.
Have received a live vaccine recently.
Have had a stem cell transplant.

Locations

FACILITY	ZIP	CITY	STATE
M D Anderson Cancer Center	77030	Houston	Texas

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