Study Comparing R-mabHD and a Combination of ABVD in Hodgkin's Disease

• Status: Unknown status
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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-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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American Scitech International
• Collaborators: Bristol-Myers Squibb; Eli Lilly and Company; ImClone LLC
• Treatments: Bleomycin; Dacarbazine; Doxorubicin; Liposomal doxorubicin; Vinblastine

Criteria

Inclusion Criteria:

1. Must sign an informed consent form

2. Must have histologically proven diagnosis of Hodgkin's lymphoma

3. Both genders and age between 18 and 65

4. Must have adequate bone marrow reserve (ANC.1500/mm3, Platelet>50,000/mm3)

5. Must have bidimensionally measureable disease

6. LVEF >50% by echocardiogram

7. Serum creatinine upto one fold

8. Serum bilirubin upto one fold

9. Hepatitis B surface antigen negative

10. 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 Criteria:

1. HIV positive

2. Pregnant women and women of child bearing age who are not practising adequate contraception

3. Severe pulmonary disease including COPD and asthma

4. Evidence of other malignancy except superficial nonmelanoma skin carcinoma or carcinoma in situ of the cervix

5. Nursing mothers

6. Uncontrolled active infection

7. concurrent prednisone or other systemic steroid therapy

8. Less than 4 weeks since prior radiotherapy

9. Less than 30 days since prior investigational therapy.