Phase 2 open-label, single-arm study of Quizartinib (AC220) monotherapy in Japanese patients with FLT3-ITD positive refractory or relapsed acute myeloid leukemia

DAIICHI SANKYO Co.,Ltd.0 个研究点目标入组 37 人开始时间: 2016年11月21日最近更新: 2023年10月17日

试验速览

阶段: 2 期
状态: 已完成
发起方: DAIICHI SANKYO Co.,Ltd.
入组人数: 37

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

Treatment with quizartinib monotherapy was well tolerated and resulted in clinically meaningful reductions in blast count in Japanese patients with FLT3-ITD positive relapsed or refractory AML.

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 20age old 至 ot applicable（—）
性别: All

入选标准

•AML patients in first relapse or refractory after all prior therapy.
•-Presence of the FLT3-ITD activating mutation in bone marrow or peripheral blood.
•-ECOG Performance Status(PS) of 0 to 2.

排除标准

•-Diagnosis of acute promyelocytic leukemia.
•-AML secondary to prior chemotherapy for other neoplasms.
•-Persistent, clinically significant > Grade 1 non-hematologic toxicity from prior AML therapy.
•-Prior treatment with a FLT3 targeted therapy.
•-Active infection not well controlled by antibacterial, antifungal and/or antiviral therapy.

研究者

发起方

DAIICHI SANKYO Co.,Ltd.

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