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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 is a Phase 2 study of PTCL that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 50 participants. The trial reports 6 study locations across 6 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04747236
The ClinicalTrials.gov registry entry for NCT04747236 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
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 reports 6 study locations spanning 6 distinct geographic areas - top geographies include 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.
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