Status:
UNKNOWN
Study Comparing R-mabHD and a Combination of ABVD in Hodgkin's Disease
Lead Sponsor:
American Scitech International
Collaborating Sponsors:
Eli Lilly and Company
Bristol-Myers Squibb
Conditions:
Hodgkin's Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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-mabH...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Must sign an informed consent form
- Must have histologically proven diagnosis of Hodgkin's lymphoma
- Both genders and age between 18 and 65
- Must have adequate bone marrow reserve (ANC.1500/mm3, Platelet\>50,000/mm3)
- Must have bidimensionally measureable disease
- LVEF \>50% by echocardiogram
- Serum creatinine upto one fold
- Serum bilirubin upto one fold
- Hepatitis B surface antigen negative
- Hodgkin's Disease patients who relapse after radiation therapy alone or surgical treatment alone or both,or previously untreated patients with stage II bulky, III and IV.
Exclusion
- HIV positive
- Pregnant women and women of child bearing age who are not practising adequate contraception
- Severe pulmonary disease including COPD and asthma
- Evidence of other malignancy except superficial nonmelanoma skin carcinoma or carcinoma in situ of the cervix
- Nursing mothers
- Uncontrolled active infection
- concurrent prednisone or other systemic steroid therapy
- Less than 4 weeks since prior radiotherapy
- Less than 30 days since prior investigational therapy.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2014
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00797472
Start Date
July 1 2011
End Date
April 1 2014
Last Update
July 20 2011
Active Locations (1)
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1
Raritan Bay Medical Center
Englishtown, New Jersey, United States, 07726