NCT06947967

Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype

A Phase III, Randomised, Double-blind, Placebo-controlled, Multicenter Study of Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype (SWIFT 02)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: Chipscreen Biosciences, Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A Randomised, Double-blind, Multicenter Phase Ⅲ Study to Evaluate the Efficacy and Safety of Tucidinostat versus Placebo in Combination with CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma with Follicular Helper of T Cell Phenotype

Detailed description

This is A Randomised, Double-blind, Multicenter Phase Ⅲ Study to Evaluate the Efficacy and Safety of Tucidinostat versus Placebo in Combination with CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma with Follicular Helper of T Cell Phenotype.Participants Will be Randomised (1:1) to ReceiveTucidinostat (Experimental Arm) or Placebo(Control Arm)in Combination with CHOP .

Conditions

• Lymphoma, T-Cell, Peripheral

Interventions

Type	Name	Description
DRUG	CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone)	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.
DRUG	Tucidinostat	oral, taking as prescribed by the protocol
DRUG	Placebo	oral, taking as prescribed by the protocol

Timeline

• Start date: 2025-08-12
• Primary completion: 2032-12-01
• Completion: 2032-12-01
• First posted: 2025-04-27
• Last updated: 2025-09-15

Locations

1 site across 1 country: China