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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

Phase II Investigational Trial Published in CANCER: the Journal of the

American Cancer Society

SEATTLE, Jan. 22 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX) announced today that results of a phase II clinical study, published in the journal CANCER demonstrate that the addition of radioimmunotherapy (RIT) to chemotherapy for previously untreated patients with non-follicular indolent non-Hodgkin's lymphoma (NHL) was both well tolerated and effective, producing a 100 percent complete remission at end of treatment with an estimated 89 percent of patients remaining in remission at three years.

The study, conducted at the Institute of Hematology and Medical Oncology at University of Bologna, Italy, investigated the use of a single dose of Zevalin(R) (Ibritumomab Tiuxetan) as consolidation therapy following treatment with a regimen of fludarabine and mitoxantrone (FM chemotherapy) among 26 patients with newly diagnosed non-follicular indolent NHL. Non-follicular lymphomas are also referred to as intermediate grade compared to the low grade follicular or high grade diffuse B cell variety. FM chemotherapy resulted in 50 percent of patients achieving a complete remission (CR) and 30 percent achieving a partial remission (PR). Of the 20 patients (13 with CR and 7 with PR) who were evaluable for Zevalin consolidation, 100 percent 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 most common greater than or equal to grade 3 toxicities included neutropenia (11 patients) and thrombocytopenia (16 patients).

"This single arm, non-randomized phase II trial provides addition
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SOURCE Cell Therapeutics, Inc.
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