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Study identifier: NCT04747236 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: PTCL  ·  Sponsor: University of Virginia

PhasePhase 2
Planned participants50
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Craig Portell, MD  ·  434-924-9637  ·  cp4ys@uvahealth.org

Marian Abdelmalek, MS  ·  434-924-8827  ·  mka6s@uvahealth.org

Always discuss trial participation with your own doctor first.

Locations (6)

VA Long Beach Health Care SystemLong Beach, California, United StatesRecruiting
Yale Cancer CenterNew Haven, Connecticut, United StatesRecruiting
Icahn School of Medicine at Mount SinaiNew York, New York, United StatesRecruiting
Duke UniversityDurham, North Carolina, United StatesRecruiting
The Ohio State UniversityColumbus, Ohio, United StatesNot Yet Recruiting
University of VirginiaCharlottesville, Virginia, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT04747236