A Phase II Study To Evaluate The Safety And Efficacy Of Zevalin (IND # BB IND 4850) Therapeutic Regimen In Patients With Transformed CD20 + B-Cell Non-Hodgkin's Lymphoma

Brief Summary

Detailed Description

OBJECTIVES: * Determine the efficacy of yttrium Y 90 ibritumomab tiuxetan and rituximab, in terms of overall response rate (complete, unconfirmed complete, and partial) and duration of response, in patients with transformed CD20+ B-cell non-Hodgkin's lymphoma. * Determine the safety of this regimen in these patients. * Determine the event-free survival and time to treatment progression in patients treated with this regimen. * Determine the immunogenicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive rituximab IV followed within 4 hours by indium In 111 ibritumomab tiuxetan IV (for imaging) over 10 minutes on day 1. Patients undergo 1 (or 2 if needed) imaging scan between days 2-5. In the absence of altered biodistribution, patients receive rituximab IV followed within 4 hours by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8. Patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 2 years.

Primary Outcomes

Secondary Outcomes

• Event-free survival(Up to 4 years)
• Time to progression(Up to 4 years)
• Time to next lymphoma treatment(Up to 4 years)
• Complete response (CR), unconfirmed CR, and partial response(Up to 4 years)