Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype
Plain-language summary
This trial is testing CHOP (cyclophosphamide for patients with various types of peripheral T-cell lymphoma (PTCL) who have been newly diagnosed and have not yet received treatment as well as those who have responded to prior therapy and may receive maintenance treatment. This is a Phase 3 trial, which means the treatment is being compared to the current standard of care to determine if it works better. Patients are randomly assigned to treatment groups, and neither patients nor doctors know which treatment is being given. The study looks at both safety and how well the treatment controls the lymphoma. This trial does not currently have sites in the United States.
Who can join (key eligibility)
- Age 18 Years to 80 Years years
- Newly diagnosed, not yet treated
- 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
CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) (DRUG): Cyclophosphamide 750 mg/m2 , intravenous infusion on day 1 of each 21-day cycle. Doxorubicin 70mg/m2 , intravenous infusion on day 1 of each 21-day cycle, total 6 cycles. Vincristine 1.4mg/m2(Max dose 2mg), intravenous injection on day 1 of each 21-day cycle , total 6 cycles. Prednisone 100 mg, oral, day 1-5 of each 21-day cycle,total 6 cycles. | Tucidinostat (DRUG): oral, taking as prescribed by the protocol | Placebo (DRUG): oral, taking as prescribed by the protocol
CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone), Tucidinostat, Placebo
- Treatment length
- Ask the trial team for details
- Visit frequency
- Ask the trial team for details