Testing a new treatment for patients with relapsed or refractory peripheral T-cell lymphoma.
Official title: A Randomized, Phase IIB, Multicenter, Trial of Oral Azacytidine Plus Romidepsin versus Investigator's Choice in Patients with Relapse or Refractory Periperal T-cell lymphoma (PTCL).
Funded at University of Virginia · NIH-10692553 · Data updated 2026-11-12
This study is looking at whether a new combination of two medications, Oral Azacytidine and Romidepsin, works better than standard treatments for people with relapsed or hard-to-treat peripheral T-cell lymphoma, to see if it can help improve their chances of survival.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Virginia NIH-funded |
| Lab location | 1 site (Charlottesville, United States) |
| Project start | August 15, 2020 |
| Project end | January 31, 2027 |
| Funding year | 2025 |
| Award (this year) | $808,684 |
| NIH project number | 5R01FD006814-03 |
| Project ID | NIH-10692553 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are patients diagnosed with relapsed or refractory peripheral T-cell lymphoma who have received at least one prior systemic therapy.
✕Less likely to help
Patients with newly diagnosed PTCL or those who have not received prior systemic therapy may not benefit from this research.
What this research studies
This research investigates the effectiveness of a combination treatment using Oral Azacytidine and Romidepsin compared to standard treatment options for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The study aims to gather data on how well this new treatment works, particularly given the unique challenges posed by the rarity and diversity of PTCL. Patients will be randomly assigned to receive either the new combination therapy or the investigator's choice of existing treatments, allowing researchers to compare outcomes. The goal is to identify a potentially more effective treatment option that could improve survival rates for patients with this aggressive cancer.
Why it matters
Potential benefit: If successful, this research could lead to improved treatment options and better survival rates for patients with relapsed or refractory PTCL.
How similar studies have gone: Other studies have shown promise with similar treatment approaches using epigenetic modifiers in PTCL, indicating potential for success in this trial.
Where this research is happening
-
University of Virginia
Charlottesville, United States Active
Researchers
- Principal investigator: O''connor, Owen a — University of Virginia
- Study coordinator: O''connor, Owen a
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.