Study Comparing R-mabHD and a Combination of ABVD in Hodgkin's Disease
Status unconfirmed · Phase 2
Conditions studied: Hodgkin's Disease
In brief
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.
Key facts
- Study ID
- NCT00797472
- Run by
- American Scitech International
- People needed
- 120
- Starts
- 2011-07-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2011-07-20
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Raritan Bay Medical Center — Englishtown, New Jersey, United States
Full record on ClinicalTrials.gov
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