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NOT YET RECRUITING
NCT06255795
PHASE3

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

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

14 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

142

Start Date

2024-02-15

Completion Date

2028-12-31

Last Updated

2024-02-13

Healthy Volunteers

No

Interventions

DRUG

chidamide, anti-PD1 antibody, and pegaspargase

6 cycles of pegaspargase 2500IU/m2 intramuscularly on day1, anti-PD1 antibody 200mg intravenously on day 2, chidamide 30mg biw orally, every 21 days.

DRUG

DDGP

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.

Locations (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, China