jRCT2080223386已完成2 期
Phase 2 open-label, single-arm study of Quizartinib (AC220) monotherapy in Japanese patients with FLT3-ITD positive refractory or relapsed acute myeloid leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Composite complete remission rate
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multi-center, single-arm, open label
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 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.
结局指标
主要结局
Composite complete remission rate
Tumor response will be assessed by the bone marrow findings, and absolute neutrophil count and platelet count in the peripheral blood.
次要结局
- Safety
- Pharmacokinetics
- Tumor response
研究者
研究点 (1)
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