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Fludarabine, Mitoxantrone and Zevalin(R) Produces 96% Complete Remission Rate in First-Line Treatment of Patients with Follicular Non-Hodgkin's Lymphoma
Date:3/16/2008

with PR) were subsequently treated with Zevalin therapy. Consolidation with Zevalin converted 12 of 14 partial remissions (86 percent) to complete remissions for a complete response rate of 96 percent. With a median follow-up of 30 months, estimated three-year progression-free survival (PFS) was 76 percent and estimated three-year overall survival 100 percent. Twenty two percent of patients tested (5 of 23) achieved a molecular remission following chemotherapy. Zevalin consolidation induced a molecular remission in 14 of 18 patients (78 percent) tested who did not achieve a molecular remission after fludarabine-mitoxantrone therapy. Grade 3/4 thrombocytopenia, neutropenia, and anemia occurred in 63 percent (36 of 57), 53 percent (30 of 57), and 23 percent (13 of 57), respectively. Febrile neutropenia occurred in 9 percent (5 of 57) of patients. Patients who relapsed were treated with CHOP + rituximab as salvage therapy and all tolerated six cycles of therapy indicating that treatment with Zevalin did not preclude the ability to administer an aggressive salvage regimen.

Details of the Study

The phase II trial, reported by P.L. Zinzani et. al. from the Institute of Hematology and Medical Oncology at the University of Bologna in Bologna Italy, was a prospective, single-arm, open-label, multi-center, non-randomized trial, known as FLUMIZ (FLUdarabine, MItoxantrone, Zevalin). The trial was conducted at 13 Italian institutions to evaluate the efficacy and safety of this regimen as first-line therapy in untreated patients with follicular non-Hodgkin's lymphoma. Patients with stage III or IV untreated indolent follicular NHL were treated with oral fludarabine and intravenous mitoxantrone every 28 days for six cycles. Patients who had at least a partial response with adequate platelet counts (>100x10^9/L) and granulocyte counts (1.5x10^9/L), and bone marrow tumor infiltration of less than 25 percent four to six weeks after completion of the sixth cycle of chem
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SOURCE Cell Therapeutics, Inc.
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