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ENROLLING BY INVITATION
NCT05678933
PHASE3

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

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2023-01-01

Completion Date

2029-12-01

Last Updated

2023-01-10

Healthy Volunteers

No

Interventions

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.

Locations (1)

Tianjin Medical University Cancer Insititute & Hospital

Tianjin, Tianjin Municipality, China