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Zevalin(R) Combined With High-Dose Chemotherapy and Autologous Stem-Cell Transplantation (ASCT) Produces High Overall Survival and Progression-Free Survival Rates in Patients With Relapsed Non-Hodgkin's Lymphoma
Date:1/17/2008

emotherapy prior to autologous stem-cell transplant is an exciting new potential application of Zevalin. We expect to explore this as an additional registration direction for Zevalin," noted Jack W. Singer, M.D. Chief Medical Officer at CTI.

The study is reported in the current issue of Journal of Clinical Oncology at http://jco.ascopubs.org/cgi/doi/10.1200/JCO.2007.11.9248.

Study Details

The trial evaluated the safety and efficacy of combining a standard dose of ZEVALIN (14.8 MBq/kg [0.4mCi/kg]) followed by high-dose BEAM and ASCT in patients with non-Hodgkin's lymphoma who were considered ineligible for total-body irradiation because of older age or prior radiotherapy. Primary endpoints of the study were overall (OS) and progression-free survival (PFS). Secondary endpoints included safety and long-term complications. Sixty patients were enrolled with 41 patients receiving full protocol of imaging and therapy. Median age of the patients treated was 59.6 years (range 19.8 to 78.9 years). Lymphoma histologies included diffuse B cell (n=20), mantle cell (n=13), follicular (n=4) and transformed (n=4). Median tumor bulk prior to treatment was 3.1cm; median number of prior therapies was 2 with range 1-6. Thirty-five of the 41 patients were alive at the time of analysis; 27 were in remission. With a median follow-up of 18.4 months (range 5.5 to 53.3 months), the Kaplan-Meier estimated 2-year OS and PFS were 88.9 percent and 69.8 percent, respectively. The primary toxicities observed included grade 3 or 4 mucositis in 21 patients, grade 3 hypoxia in eight patients, and grade 3 pneumonitis, which responded to corticosteroids, in 3 patients. Transplantation-related mortality at 100 days was 0 percent. The authors concluded: "Combining 90Y ibritumomab tiuxetan with high dose BEAM before ASCT is feasible with no evidence of increase toxicity. The high rates of PFS, especia
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SOURCE Cell Therapeutics, Inc.
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