Study Evaluating the Effect of R-mabHDI in Lymphocytic Predominant Hodgkin's Lymphoma
Sponsored by American Scitech International
Objective: The primary objective of the study is to evaluate the effect of R-mabHDI in patients with late stage, widespread stage and recurrent Lymphocytic Predominant Hodgkin's Lymphoma. The hypothesis is that the combination of R-mabHDI with the standard ABVD therapy in patients with late stage (Stage III and Stage IV) and recurrent stage Lymphocytic Predominant Hodgkin's Lymphoma will have a favorable outcome on the response and progress free survival. The study is also aimed at evaluating the safety of R-mabHDI . The aim of the study is to test this hypothesis by evaluating the clinical outcome in 1200 patients receiving combination of R-mabHDI once a week for 8 weeks and ABVD therapy every other week for 12 treatments.
Patients with proven diagnosis of Lymphocytic Predominant Hodgkin's Lymphoma in late stage HD, widespread HD and recurrent HD on histology
Patients of both gender
Patients between ages of 16 and 65 years
Patients must have bi-dimensionally measurable disease
Patients with adequate bone marrow reserve (ANC>1500/mm3 ; Platelets> 50,000/ mm3)
LVEF >/= 50% as measured by echocardiogram
Serum creatinine < 2mg/dl
Serum bilirubin < 2mg/dl; AST or ALT < 2x ULN
International Prognostic Score of >2 (Patients must have > 2 of the following risk features: Male >/= 45 years of age, Stage IV, Albumin <4, WBC >/= 15, Lymphocytes < 8% or < 600, Hb < 10.5)
Classic Hodgkin's disease
Known HIV infection
Pregnant women and women of child bearing capacity, tests positive on a urine/blood pregnancy test, is lactating/nursing, has had three or more days of amenorrhea at the time of first dose of the treatment, is contemplating pregnancy in next six months or is not using an efficient contraceptive method
Severe pulmonary disease as judged by the Principal Investigator including COPD and asthma
Acute infection requiring treatment with intravenous therapy
Presence of CNS lymphoma
Concomitant malignancies or previous malignancies within the last 5 years
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