A Phase II Randomized Study of Rituximab-HCVAD alternating with Rituximab-Methotrexate-Cytarabine versus Standard Rituximab-CHOP Every 21 Days for Patients With Newly Diagnosed High Risk Aggressive B-Cell Non-Hodgkin's Lymphomas in Patients 60 Years Old or Younger
The overall goal of this clinical research study was to find out which of two different chemotherapy drug combinations, R-CHOP and R-HCVAD, is more effective in treating B-cell lymphoma. At this point, all participants will now be assigned to the R-HCVAD arm of the study. Researchers will study the safety and effectiveness of this drug combination.
Treatment Location: N/A
1. To evaluate the Overall response rate (ORR), Complete Response (CR + Cru), Disease-free survival (DFS), and progression-free survival (PFS) rate following therapy with Rituxan-HCVAD alternating with Rituximab with high-dose methotrexate/ara-C and standard R-CHOP in patients with newly diagnosed B-cell aggressive non-Hodgkin’s lymphomas younger than 60 years old and with adjusted IPI 2 or higher adverse prognostic features. Progression-free survival will be done for 3-years 2. Secondary objectives include: overall survival, toxicity profile.
IRB Review and Approval Date: MAR 2,2005
Recruitment Status: Closed
Projected Accrual: N/A