Procarbazine Hydrochloride Capsule (Natulan®) Clinical Trial Protocol

NAUnknownINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

December 31, 2018

Study Completion Date

December 31, 2018

Conditions
Advanced Hodgkin's Lymphoma
Interventions
DRUG

Natulan

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

DRUG

ABVD

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;

Sponsors
All Listed Sponsors
lead

Lee's Pharmaceutical Limited

INDUSTRY