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NCT04747236 · ClinicalTrials.gov registry record · Phase 2
Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL
A Phase 2 study of PTCL, sponsored by University of Virginia.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 6
- Study locations
NCT04747236: Recruiting Phase 2 study of PTCL, sponsored by University of Virginia.
NCT04747236 is a Phase 2 study of PTCL that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04747236, a Phase 2 study of PTCL, is actively recruiting participants, sponsored by University of Virginia.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
Difference in progression free survival in subjects treated with AZA/ROMI versus pre-specified investigator choice.
Conditions Studied
Interventions
- DRUG Gemcitabine
- DRUG Belinostat
- DRUG Pralatrexate
- DRUG Romidepsin
- DRUG Azacytidine
Study Locations (6)
California
- VA Long Beach Health Care System - Long Beach
Connecticut
- Yale Cancer Center - New Haven
New York
- Icahn School of Medicine at Mount Sinai - New York
North Carolina
- Duke University - Durham
Ohio
- The Ohio State University - Columbus
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-02-19 |
| Est. Completion | 2030-06-02 |
| Phase | Phase 2 |
What NCT04747236 shows while recruiting
NCT04747236 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 1 condition, with PTCL appearing as the primary indexed condition, and to 5 interventions - of which Gemcitabine is the first listed.
NCT04747236 lists 6 locations in 6 states (California, Connecticut, New York).
Frequently Asked Questions
What is clinical trial NCT04747236 about?
NCT04747236 is a clinical study titled "Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL". 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 dr...
What is the current status of trial NCT04747236?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2021-02-19. Estimated completion is 2030-06-02.
What conditions does trial NCT04747236 study?
This clinical trial studies the following conditions: PTCL.
What interventions are being tested in trial NCT04747236?
The interventions under investigation include: Gemcitabine (DRUG), Belinostat (DRUG), Pralatrexate (DRUG), Romidepsin (DRUG), Azacytidine (DRUG).
Who is sponsoring clinical trial NCT04747236?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04747236 being conducted?
This trial has 6 study locations across California, Connecticut, New York, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for PTCL
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04747236's enrollment target sits among peer trials
50 1195th of 2000 higher than 741 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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