Clinical trialNCT04747236RecruitingPhase 2Interventional

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

SponsorUniversity of VirginiaEnrollment50PTCL

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Craig Portell, MD
University of Virginia
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Va Long Beach Health Care System
Long Beach, California, United States
Helen Ma, MDPankaj Gupta, MD
Recruiting
Yale Cancer Center
New Haven, Connecticut, United States
Francesca Montanari, MD
Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Suchitra Sundaram, MD
Recruiting
Duke University
Durham, North Carolina, United States
Recruiting
the Ohio State University
Columbus, Ohio, United States
Not, yet, recruiting
University of Virginia
Charlottesville, Virginia, United States
Craig Portell, MD
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Azacitidine →Belinostat →Gemcitabine →PralatrexateRomidepsin →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 19 Feb 2021
Primary completion: 2 Jun 2028
Completion: 2 Jun 2030
Last update posted: 21 Jan 2026
Registered enrollment: 50
Registry id: NCT04747236

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.