A Phase II Open Label, Multicenter, Randomized, Parallel Study Comparing the Efficacy of R-mabHD Alone and a Combination of Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD)in Treating Patients With Hodgkin's Disease.
The primary objective is to compare the efficacy of R-mabHD with a combination therapy of
Adriamycin, Bleomycin,Vinblastine and Dacarbazine (ABVD) in bringing about remission of
Hodgkin's lymphoma and reduction in tumor size.
Primary Study Endpoint: Primary efficacy criterion is percentage of patients achieving a
functional score of 1.
Efficacy evaluation is based on assessment of functional score. At the end of six months, a
functional assessment of the tumor will be undertaken to record the score as follows:
Score 1: >/= 50% reduction in size of tumor Score 2: < 50% reduction in size of tumor.
Secondary Study Endpoint: Additional secondary endpoint is the average time to achieve 50%
reduction in size of tumor.
120 subjects with Hodgkin's Disease will be divided randomly into two groups. 60 subjects
(Group I)will receive R-mabHD by intravenous infusion in a dose of 375mg/m2 once a week for
eight weeks in a row. The other half (Group II) will receive a combination of intravenous
Adriamycin, Bleomycin, Vinblastine and Dacarbazine every other week for 12 treatments.
Enrollment period will be three years and subjects from both genders will be accepted.
Subjects should be between the ages of 18 and 65. No healthy volunteers will be accepted.
Females who are nursing babies or are pregnant will be excluded from the study. Subjects
will be evaluated every month for the first six months and then at one year and then at
eighteen months after the baseline visit one.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
There will be a reduction in the size of the tumor after initiating treatment.
Ratna Grewal, M.D.
American Scitech International
United States: Institutional Review Board
|Raritan Bay Medical Center||Perth Amboy, New Jersey 08861|