Clinical Trial

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

Study acronym: PTCL
Recruiting Phase 2
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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.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2021-02-05; most recent amendment 2026-01-20.
Status change: Not Yet Recruiting → Recruiting 2021-03-16
Trial Details
NCT Number NCT04747236
Lead Sponsor University of Virginia
Collaborators: Celgene
Conditions PTCL
Enrollment 50 participants
Start Date 2021-02-19
Primary Completion 2028-06-02 (estimated)
Study Completion 2030-06-02 (estimated)
Updated on ClinicalTrials.gov 2026-01-21