Yttrium-90 Ibritumomab Tiuxetan (Zevalin) With BEAM in Relapsed Low Grade B-Cell Lymphoma

Summary

The objective of this study is to evaluate the efficacy and the safety of Zevalin-BEAM preparative regimen before autologous stem cell transplantation (ASCT) as measured by the event free survival (EFS). The goal is to obtain a 15% increase of EFS at 2 years.

Timeline

Start

2005-03

Primary completion

—

Completion

2009-03

Publications

• Background Brice P, Simon D, Bouabdallah R, Belanger C, Haioun C, Thieblemont C, Tilly H, Harousseau JL, Doyen C, Martin C, Brousse N, Solal-Celigny PH; Groupe d'Etude des Lymphomes de l'Adulte (GELA). High-dose therapy with autologous stem-cell transplantation (ASCT) after first progression prolonged survival of follicular lymphoma patients included in the prospective GELF 86 protocol. Ann Oncol. 2000 Dec;11(12):1585-90. doi: 10.1023/a:1008399623564.
• Background Mills W, Chopra R, McMillan A, Pearce R, Linch DC, Goldstone AH. BEAM chemotherapy and autologous bone marrow transplantation for patients with relapsed or refractory non-Hodgkin's lymphoma. J Clin Oncol. 1995 Mar;13(3):588-95. doi: 10.1200/JCO.1995.13.3.588.
• Background Witzig TE, White CA, Gordon LI, Wiseman GA, Emmanouilides C, Murray JL, Lister J, Multani PS. Safety of yttrium-90 ibritumomab tiuxetan radioimmunotherapy for relapsed low-grade, follicular, or transformed non-hodgkin's lymphoma. J Clin Oncol. 2003 Apr 1;21(7):1263-70. doi: 10.1200/JCO.2003.08.043.
• Background Fung HC, Forman SJ, Nademanee A, Molina A, Yamauchi D, Speilberger R, Kogut N, Sahebi F, Parker P, Rodriguez R, Krishnan A, Popplewell L, Wong J, and Raubitschek A. A new preparative regimen for older patients with aggressive CD20-positive B-cell lymphoma utilizing standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) radioimmunotherapy (RIT) combined with high-dose BEAM followed by autologous hematopoietic cell transplantation (AHCT) : targeted intensification without increased transplant-related toxicity. Blood 2003, forty-fifth annual meeting of the American Society of Hematology, abstract 870.
• Background Nademanee A, Forman SJ, Molina A, Kogut N, Fung HC, Yamauchi D, Anderson A-L, Smith D, Liu AN, and Raubitschek A. High-dose radioimmunotherapy with yttrium 90 (90Y) ibritumomab tiuxetan with high-dose etoposide (VP-16) and cyclophosphamide (CY) followed by autologous hematopoietic cell transplantation (AHCT) for poor-risk or relapsed B-cell non-Hodgkin's lymphoma (NHL): update of a phase I/II trial. J Clin Oncol 2004, fortieth annual meeting of the American Society of Clinical Oncology, abstract 6504.

Drugs

Indications