The Efficacy and Safety of Chidamide, Anti-PD-1 Antibody in Combination With Pegaspargase Versus DDGP in the Treatment of Newly Diagnosed, Stage III to IV Extranodal Natural Killer/T-Cell Lymphoma
Plain-language summary
This trial is testing chidamide (an oral HDAC inhibitor) for patients with extranodal NK/T-cell lymphoma (ENKTL) who have been newly diagnosed and have not yet received treatment as well as those whose disease has come back or stopped responding to prior 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 different treatment groups. 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 14 Years to 70 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
chidamide, anti-PD1 antibody, and pegaspargase (DRUG): 6 cycles of pegaspargase 2500IU/m2 intramuscularly on day1, anti-PD1 antibody 200mg intravenously on day 2, chidamide 30mg biw orally, every 21 days. | DDGP (DRUG): 6 cycles of pegaspargase 2500IU/m2 intramuscularly on day1, cisplatin 20mg/m2 intravenously on days 1 through 4, dexamethasone 15mg/m2 intravenously on days 1 through 5, gemcitabine 800mg/m2 on day 1 and day 8, every 21 days.
chidamide, anti-PD1 antibody, and pegaspargase, DDGP
- Treatment length
- Ask the trial team for details
- Visit frequency
- Ask the trial team for details