Extranodal Natural Killer T Cell Lymphoma Clinical Trial
Official title:
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
A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of chidamide, anti-PD1 antibody, and pegaspargase versus dexamethasone, cisplatin, gemcitabine, and pegaspargase (DDGP) in the treatment of newly diagnosed, stage III to IV extranodal natural killer/T-cell lymphoma.
This study will evaluate the efficacy and safety of chidamide, anti-PD1 antibody, and pegaspargase versus DDGP in the treatment of newly diagnosed, stage III to IV extranodal natural killer/T-cell lymphoma. Subjects will be randomly assigned 1:1 to chidamide, anti-PD1 antibody, and pegaspargase or DDGP regimen. Patients in chidamide, anti-PD1 antibody, and pegaspargase group will receive 6 cycles of pegaspargase 2500IU/m2 intramuscularly on day1, anti-PD1 antibody 200mg intravenously on day 2, chidamide 30mg biw orally, every 21 days. Patients in DDGP group will receive 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. ;