Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL
Plain-language summary
This Phase 2 trial is comparing Azacytidine, Romidepsin, and other medications against other options for people whose T-cell lymphoma has come back or has not responded to previous treatment. Patients are randomly assigned to different treatment groups to see which approach works best. It is available at 6 US locations across multiple states.
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)
- May require specific number of prior treatments
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.
- Drugs / treatments
- Azacytidine, Romidepsin, Belinostat, Pralatrexate, Gemcitabine
- Treatment length
- Ask the trial team for details
- Visit frequency
- Ask the trial team for details