1. To observe and compare the overall response rate (ORR) of baseline BEACOPP and ABVD regimens for patients with advanced Hodgkin's lymphoma. 2. To evaluate the safety of Natulan® in Chinese patients with advanced Hodgkin's lymphoma
This is a confirmatory open-label, randomized, controlled, multicenter study. Recruited subjects are to be randomized to treatment group and controlled group, with ratio of 1:1. Treatment group will accept baseline BEACOPP regimen, while controlled group will accept ABVD regimen. The study design consisted of a screening phase of 1 week, a treatment phase of 24 or 32 weeks, and a post treatment follow-up of at least 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Each baseline BEACOPP regimen lasts 21 days, and each cycle consists of: Cyclophosphamide injection: 650mg/m2, IV infusion, day 1; Doxorubicin hydrochloride injection: 25mg/m2, IV infusion, day 1; Etoposide injection: 100mg/m2, IV infusion, day 1\~3; Natulan (procarbazine hydrochloride capsule): 100mg/m2,po, day 1\~7; Bleomycin hydrochloride injection: 10mg/m2, IV or IM, day 8; Vincristine: 1.4mg/m2 (single maximum dose is 2mg), IV infusion, day 8; Prednisone tablet: 40mg/m2, po, day 1\~14
Each ABVD cycle lasts 28 days1 cycle of the ABVD regimen consists of: Doxorubicin hydrochloride injection:25mg/m2,IV infusion,day 1 and 15; Dacarbazine injection:375mg/m2,IV infusion,day 1 and 15; Bleomycin injection:10mg/m2,IV or IM,day 1 and 15; Vincristine injection:1.4mg/m2 (single maximum dose is 2mg), IV infusion,day 1 and 15;
overall response rate (ORR)
Compare the overall response rate (ORR) of baseline BEACOPP and ABVD regimens for in patients with advanced Hodgkin's lymphoma.
Time frame: 45 months
safety as measured by changes of vital signs, ECG and AE number
Time frame: 45 months
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