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CHOP-Zevalin(R) Investigational Regimen Produces 95% Complete Remission and 75% Estimated Two Year Progression-Free Survival in Elderly Patients with Diffuse Large B-cell Lymphoma
Date:3/5/2008

om the Phase III FIT study. We are currently testing this clinically important potential of Zevalin consolidation in our ongoing phase III post-marketing commitment trial."

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 and the Department of Nuclear Medicine at S. Orsola-Malpighi Hospital in Bologna Italy, was a prospective, single-arm, open-label, non-randomized study combining CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone) plus Zevalin, which was conducted to evaluate the efficacy and safety of this regimen as first-line therapy in elderly (60 years of age or older) DLBCL patients. The ORR was 100 percent, including 95 percent CR and 5 percent partial remission (PR). Four (80 percent) of the five patients who achieved less than a CR with CHOP improved their remission status after receiving Zevalin. With a median follow-up of 15 months, the 2-year progression-free survival was estimated to be 75 percent, with a 2-year overall survival of 95 percent. The toxicity associated with Zevalin included severe (grade 3 or 4) hematologic toxicity in 12 of 20 patients; the most common severe side effects were neutropenia (12 patients) and thrombocytopenia (7 patients). Transfusions of platelets were given to one patient.

About Zevalin(R)

Zevalin(R) (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated for the treatment of patients with relapsed or refractory low-grade or follicular B-cell NHL, including patients with Rituximab-refractory NHL. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.

Rare deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab infusions. Yttrium-90 Zevalin administration results in severe and prolonged cytopenias in most patient
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SOURCE Cell Therapeutics, Inc.
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