Study Comparing R-mabHD and a Combination of ABVD in Hodgkin's Disease
Recruitment status was: Not yet recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- There will be a reduction in the size of the tumor after initiating treatment. [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
- There will be an improvement in the general condition of the patient and it will be possible to estimate the event free survival rate. [ Time Frame: Eighteen months ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Arm I: R-mabHD
Anti-hodgkin disease agent
An intravenous infusion containing R-mabHD 375mg/m2 will be administered over a period of 3 to 8 hours every week for eight weeks in a row.
|Active Comparator: Arm II: ABVD||
A combination of Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD) will be given intravenously over a period of 3 hours every other week for 12 treatments.
Other Name: Adriamycin, Bleomycin, Vinblastine, Dacarbazine
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797472
|United States, New Jersey|
|Raritan Bay Medical Center|
|Englishtown, New Jersey, United States, 07726|
|Study Chair:||Ratna Grewal, M.D.||American Scitech International|
|Principal Investigator:||Prem A Nandiwada, M.D.||Raritan Bay Medical Center|