NCT02113319已完成2 期
An Open-Label, Multicenter, Phase II Study to Assess Dasatinib in Patients With Core Binding Factors Acute Myelogenous Leukemia Refractory to Conventional Chemotherapy or in Molecular Relapse. Intergroupe Français Des leucémie aiguë myéloblastique
University Hospital, Angers1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2007年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- measure relapse-free survival
研究概览
简要总结
In patients with Core Binding Factors Acute Myelogenous Leukemia, the level of Minimal Residual Disease after chemotherapy is predictive of relapse. The relapse risk is also increased in case of mutations of receptors tyrosine kinase. For patients with a high Minimal Residual Disease level at the end of consolidation or in molecular relapse, maintenance by the inhibitor dasatinib is proposed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient presenting de novo or secondary Core Binding Factors Acute Myelogenous Leukemia
- •Patient in first and presenting one of following criteria:
- •"Resistant" Patient: decrease of less than 3 log of the Acute Myelogenous Leukemia transcript level in the bone marrow after 2 consolidations
- •Patient in " molecular relapse ": increase of of more than 1 log of the Core Acute Myelogenous Leukemia transcript level on two successive marrow samples
排除标准
- •Woman of childbearing potential
- •Concurrent incurable malignacy other than Acute Myelogenous Leukemia
研究组 & 干预措施
dasatinib
Experimental
干预措施: dasatinib (Drug)
结局指标
主要结局
measure relapse-free survival
时间窗: 4 years
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
次要结局
未报告次要终点
研究者
研究点 (1)
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