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AC-CHOP Versus CHOP in Patients With Previously Untreated PTCL-TFH
Sponsor: Tianjin Medical University Cancer Institute and Hospital
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
Azacitidine
Azacitidine (75mg/ m2) will be administered at day 1-5 by subcutaneous injection of each 21-day cycle.
Chidamide
Chidamide (20 mg) will be taken orally twice a week for two weeks of each 21-day cycle.
Cyclophosphamide
Cyclophosphamide (750 mg/ m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
Epirubicin
Epirubicin (70mg/ m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
Vincristine
Vincristine (1.4mg/ m2,Max dose 2mg) will be administered by an intravenous injection on day 1of each 21-day cycle.
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