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Novel therapeutic agents provide hope for patients with hard-to-treat blood disorders
Date:12/9/2012

ells to either die immediately or undergo maturation (and eventually die). This eliminates enough leukemia cells to make it possible for patients to undergo stem cell transplants that can cure their disease.

In order to assess the efficacy and safety of quizartinib as a single agent (drug used alone in treatment) in AML patients with the FLT3-ITD mutation, researchers conducted a Phase II study among 333 patients that were divided into two treatment cohorts. Cohort 1 consisted of patients age 60 or over with the FLT3-ITD mutation who failed to achieve remission with standard chemotherapy, or who had recently relapsed for the first time. Cohort 2 consisted of patients over age 18 with the FLT3-ITD mutation who presented with relapsed or refractory AML and had been administered salvage chemotherapy after failing to respond to prior treatment, or had relapsed after a stem cell transplant. Most patients in this study had the FLT3-ITD mutation, but a small number in each cohort lacked the mutation.

Study results from Cohort 2 were based on an analysis of 137 patients (99 with mutation and 38 without) who received continuous treatment with quizartinib at a fixed dose during 28-day cycles. The primary endpoint of the study was the composite complete remission rate (CRc) of all patients, which includes complete remission (CR; no active disease), complete remission with incomplete platelet recovery (CRp, no active disease but abnormal platelet count), and complete remission with incomplete hematologic recovery (Cri, no active disease but abnormal red and white blood cell counts) of the patients following treatment with quizartinib.

Following one to three cycles of quizartinib treatment, researchers observed a CRc rate of 44 percent (4% CR, 0 CRp, and 40% CRi) in patients with the FLT3-ITD mutation with a median duration of response of 11.3 weeks and median overall survival of 23.1 weeks. In patients without the mutation, researchers observed a 34
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Contact: Andrea Slesinski
aslesinski@hematology.org
614-352-5096
American Society of Hematology
Source:Eurekalert

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