NCT00298987已完成2 期
Study of Dasatinib (BMS-354825) in Subjects With Chronic Myelogenous Leukemia With Accelerated or Myeloid or Lymphoid Blast Phase or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant to or Intolerant of Imatinib Mesylate
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2006年2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
- 400
- 试验地点
- 1
- 主要终点
- Provide therapy to patients for which there is no therapeutic alternative
研究概览
简要总结
The purpose of this clinical research study is to provide dasatinib treatment to patients with advanced chronic myelogenous leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who no longer can tolerate treatment with imatinib. The safety of the treatment will also be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of accelerated phase or blast phase CML or Ph+ ALL
- •Intolerant or resistant to imatinib mesylate
- •18 years of age or older
- •ECOG performance 0-2 (greater than 50% of time out of bed)
- •Adequate liver and kidney function
排除标准
- •Pregnant or breastfeeding females
- •History of significant cardiac disease
- •History of significant bleeding disorder (not CML)
- •Prisoners
研究组 & 干预措施
A1
Experimental
干预措施: Dasatinib (Drug)
结局指标
主要结局
Provide therapy to patients for which there is no therapeutic alternative
次要结局
- Safety data collection
研究者
研究点 (1)
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