Hodgkin's Disease Clinical Trial
Official title:
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.
120 subjects with Hodgkin's disease will be randomly divided into two groups: Group I receiving R-mabHD and Group II receiving a combination of Adriamycin,Bleomycin,Vinblastine and Dacarbazine. R-mabHD will be given once a week for eight weeks in a row. The ABVD combination will be given once every other week for 12 treatments. The hypothesis is that intervention with R-mabHD will lead to a quicker remission of Hodgkin's disease than the intervention with a combination of ABVD.
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
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