drugset / Trial / NCT06255795
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
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-02-15
- Primary completion
- 2026-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cisplatin | Other / unclassified | 20 mg/m2 | Intravenous |
| Comparator | Dexamethasone | Small molecule | 15 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 800 mg/m2 | — |
| Subject | Tucidinostat | Small molecule | 30 mg | Oral |
| Background | Pegaspargase | Protein / enzyme biologic | 2500 unknown | Intramuscular |