A Randomized Phase II Study of Rituximab with ABVD versus Standard ABVD for Patients with Advanced-Stage Classical Hodgkin Lymphoma with Poor Risk Features (IPS Score greater than 2)
The standard treatment for most patients with newly diagnosed Hodgkinâ??s lymphoma is a chemotherapy combination called ABVD, which stands for the following drug names: adriamycin (Doxorubicin), bleomycin, vinblastine, and dacarbazine. In this study, we are combining ABVD with a drug called rituximab (also called â??Rituxanâ??). Rituximab is an antibody that â??attacksâ?? certain lymphoma cells as well as normal antibody producing lymphocytes called B cells. Rituximab is FDA approved and commercially available. The combination of ABVD with rituximab is considered investigational. This research is being done to find out whether adding Rituximab to the standard treatment of Hodgkinâ??s Lymphoma can improve the treatment, and also to better understand how rituximab might work in this type of lymphoma.
a. Previously untreated patient with classical Hodgkin's lymphoma patients with stage III and IV. b. International Prognostic Score of greater than 2 (patient must have greater than 2 of the following risk features: Male, â?¥ to 45 years of age, Stage IV, Albumin less than 4, WBC â?¥ to 15, Lymphocytes less than 8% or less than 600, Hgb less than 10.5) c. Must sign a consent form d. Must be older than 16 years e. Must have adequate bone marrow reserve (ANC â?¥ 1,500/uL, Platelet greater than 100,000/uL) f. LVEF â?¥ to 50% by MUGA scan or echocardiogram g. Serum creatinine less than 2 mg/dl, serum bilirubin less than 2 mg/dl, AST or ALT less than 2x ULN h. Bi-dimensionally measurable disease i. No pregnant women or women of child bearing age who are not practicing adequate contraception j. No concomitant malignancies or previous malignancies within the last 5 years (exception made for adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of cervix) k. No Lymphocyte Predominent Hodgkinâ??s Lymphoma
You will be assigned to either Group 1 or 2. Group 1 will receive ABVD with rituximab. Group 2 will receive ABVD only. Group 1 and 2 will receive IV ABVD on day 1 and 15 of each cycle. Each cycle is 4 weeks. IV Rituximab will only be given to Group 1, and only during cycle 1 and 2: Days 1, 8, 15, and 22 for cycle 1, and Days 1 and 8 for cycle 2. You may remain on study for up to 6 cycles.
05/24/2013 04:02 AM