RecruitingPhase 2NCT04747236

Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL

A Randomized, Phase IIB, Multicenter, Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in Patients With Relapse or Refractory Peripheral T-cell Lymphoma (PTCL)


Sponsor

University of Virginia

Enrollment

50 participants

Start Date

Feb 19, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to find out whether the combination treatment of romidepsin and oral azacytidine is safe and effective in patients with Peripheral T-Cell Lymphoma (PTCL). This study will compare the experimental combination treatment of romidepsin and oral azacytidine to single agent drugs already determined effective in patients with PTCL. For the purposes of this study, the single agent drugs already used to treat lymphoma are called investigator's choice (IC), meaning the investigator will choose which one of these drugs to administer. The IC drug options include romidepsin, belinostat, pralatrexate or gemcitabine given alone. Funding Source: FDA OOPD.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares a combination of two drugs (oral azacitidine plus romidepsin) against the doctor's choice of standard treatment for people with peripheral T-cell lymphoma (PTCL) — a type of aggressive blood cancer — that has come back or stopped responding after prior therapy. **You may be eligible if...** - You have been diagnosed with relapsed or refractory peripheral T-cell lymphoma (confirmed by biopsy) - Your lymphoma has come back after at least one, but no more than three, prior treatment regimens - You are 18 or older with adequate organ function - You have at least one measurable tumor that can be tracked on imaging **You may NOT be eligible if...** - You have already had more than 3 prior lines of therapy - You have had a prior allogeneic (donor) stem cell transplant - You have significant heart problems (prolonged QT interval) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzacytidine

Azacytidine, 300 mg po daily on Days 1-14

DRUGRomidepsin

Romidepsin, 14 mg/m2 as an intravenous infusion over 4 hours on Days 8, 15, and 22 of a 35-day cycle

DRUGBelinostat

Belinostat, 1000 mg/m2 as an intravenous infusion over 30 minutes on Days 1-5 every 21 days.

DRUGPralatrexate

Pralatrexate, 30 mg/m2 as an intravenous infusion over a 3-5 minute push once weekly for 6 weeks of a 7 week treatment cycle.

DRUGGemcitabine

Gemcitabine, 1000 mg/m2 as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of a 28 day cycle.


Locations(6)

VA Long Beach Health Care System

Long Beach, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Duke University

Durham, North Carolina, United States

The Ohio State University

Columbus, Ohio, United States

University of Virginia

Charlottesville, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT04747236


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