NCT05075460

Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma

A Prospective, Multicenter, Phase III, Non-randomized Study of Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 107 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, phase III study of Tucidinostat, Azacitidine combined with CHOP versus CHOP in patients with untreated peripheral T-cell lymphoma

Detailed description

Tucidinostat, a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. Azacytidine is a hypomethylating agent. The aim of this study is to compare the efficacy and safety of azacytidine, tucidinostat combined with CHOP regimen and classical CHOP regimen in the treatment of primary PTCL

Conditions

• T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Tucidinostat, Azacitidine combined with CHOP	Azacitidine: 200 mg D1200 mg D2100 mg D3 subcutaneous injection Tucidinostat: 20mg / time, D1, 4, 8, 11; Take medicine with 200ml warm boiled water 30 minutes after breakfast. CHOP chemotherapy: * Cyclophosphamide (CTX) 750mg / m2 intravenous infusion, day 1; * Epirubicin (EPI) 70mg / m2 intravenous infusion, day 1; * Vinoresin (VDS) 4mg intravenous infusion, day 1; * Prednisone 100mg orally, day 1-5. Every 21 days is a course of treatment

Timeline

• Start date: 2021-10-01
• Primary completion: 2024-05-30
• Completion: 2024-10-30
• First posted: 2021-10-12
• Last updated: 2024-04-09

Locations

1 site across 1 country: China