NCT05678933

AC-CHOP Versus CHOP in Patients With Previously Untreated PTCL-TFH

Phase 3 Multi-center Randomized Study to Compare Efficacy and Safety of Azacitidine and Chidamide Combined With CHOP (AC-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma With T-follicular Helper Phenotype (PTCL-TFH)

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is an open label, multicenter study. Subjects are randomized at a 1:1 ratio to receive either (arm A) azacitidine administered IH at day 1-5 and chidamide admistered twice a week for two weeks in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) or (arm B) CHOP administered every 3 weeks for 6 cycles in patients with previously untreated peripheral T-cell lymphoma.

Conditions

• Peripheral T-cell Lymphoma Targeted Therapy

Interventions

Type	Name	Description
DRUG	Azacitidine	Azacitidine (75mg/ m2) will be administered at day 1-5 by subcutaneous injection of each 21-day cycle.
DRUG	Chidamide	Chidamide (20 mg) will be taken orally twice a week for two weeks of each 21-day cycle.
DRUG	Cyclophosphamide	Cyclophosphamide (750 mg/ m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
DRUG	Epirubicin	Epirubicin (70mg/ m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
DRUG	Vincristine	Vincristine (1.4mg/ m2，Max dose 2mg) will be administered by an intravenous injection on day 1of each 21-day cycle.
DRUG	Prednisone	Prednisone (100 mg) will be taken orally from day 1-5 of each 21-day cycle.

Timeline

• Start date: 2023-01-01
• Primary completion: 2027-12-01
• Completion: 2029-12-01
• First posted: 2023-01-10
• Last updated: 2023-01-10

Locations

1 site across 1 country: China