NCT02800447

Procarbazine Hydrochloride Capsule (Natulan®) Clinical Trial Protocol

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Advanced Hodgkin's Lymphoma

Interventions

Type	Name	Description
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;

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2016-06-15
• Last updated: 2018-09-04