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Phase II Study of Zevalin(R) Consolidation Following Fludarabine and Mitoxantrone Chemotherapy Results in 100 Percent Complete Remission Rate and 89 Percent Three-Year Progression Free Survival in Patients with Previously Untreated Non-Follicular Indolent
Date:1/22/2008

al insights into the potential utility of RIT in intermediate grade NHL, a subtype where CRs are infrequent with rituximab therapy," noted Jack W. Singer, M.D., Chief Medical Officer of CTI.

The study results are reported in the current issue of CANCER at http://www3.interscience.wiley.com/journal/104532863/issue

Study Details

Between February 2005 and June 2006 26 eligible patients with previously untreated, indolent, nonfollicular NHL (10 marginal zone, 8 lymphocytoplasmic, and 8 small lymphocytic) were treated using a novel regimen that consisted of 6 cycles of fludarabine/mitoxantrone (FM) chemotherapy followed 6 to 10 weeks later by yttrium-90(90Y) ibritumomab tiuxetan (Zevalin(R)). After chemotherapy the overall response rate was 80.5% and included 50% CR and 30.5% PR. Of the 20 patients (13CR/7PR) who were evaluable (at least a PR with normal platelet counts and bone marrow infiltration <25%) for subsequent Zevalin, 100% obtained a CR at the end of treatment. With a median follow up of 20 months, the estimated three-year progression free survival (PFS) was 89.5 percent. The FM treatment was well-tolerated; there were no treatment-related deaths. Reversible hematologic toxicities included neutropenia grade 4 in 5 patients and grade 3 in 13 patients. Only 1 patient developed febrile neutropenia. Following Zevalin administration grade 3-4 thrombocytopenia occurred in 16 of 20 patients with grade 3-4 neutropenia reported in 11 of 20 patients. Four patients received GCSF and 3 patients received platelet transfusions. Only 1 patient experience febrile neutropenia. The authors concluded "In this study we established the feasibility, tolerability and efficacy of sequential treatement with 6 cycles of FM chemotherapy followed by 90Y ibritumomab tiuxetan as front line therapy for patients with untreated, indolent, nonfollicular NHL. To our knowledge the data repr
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SOURCE Cell Therapeutics, Inc.
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