Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL
Plain-language summary
This trial is testing Azacytidine for patients with various types of peripheral T-cell lymphoma (PTCL) whose disease has come back or stopped responding to prior treatment. This is a Phase 2 trial, which means researchers are studying how well the treatment works and monitoring for side effects. Patients are randomly assigned to different treatment groups. This trial is available at 6 locations in the United States. The trial is currently recruiting patients.
Who can join (key eligibility)
- Age 18 Years or older
- Lymphoma came back or did not respond to prior treatment
- Must be well enough for treatment (adequate performance status)
Final eligibility is determined by the trial team. This list is a starting point only.
What's being tested
Azacytidine (DRUG): Azacytidine, 300 mg po daily on Days 1-14 | Romidepsin (DRUG): Romidepsin, 14 mg/m2 as an intravenous infusion over 4 hours on Days 8, 15, and 22 of a 35-day cycle | Belinostat (DRUG): Belinostat, 1000 mg/m2 as an intravenous infusion over 30 minutes on Days 1-5 every 21 days. | Pralatrexate (DRUG): Pralatrexate, 30 mg/m2 as an intravenous infusion over a 3-5 minute push once weekly for 6 weeks of a 7 week treatment cycle. | Gemcitabine (DRUG): Gemcitabine, 1000 mg/m2 as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of a 28 day cycle.
Azacytidine, Romidepsin, Belinostat, Pralatrexate, Gemcitabine
- Treatment length
- Ask the trial team for details
- Visit frequency
- Ask the trial team for details