NCT00872976撤回1 期
Phase 1 Trial of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia
Bristol-Myers Squibb1 个研究点 分布在 1 个国家开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Determine the maximum tolerated dose (MTD) as assessed by measuring dose limiting toxicities (DLT) at each dosing level
研究概览
简要总结
The purpose of this study is to determine the recommended dose for the combination of dasatinib and bendamustine in chronic lymphocytic leukemia (CLL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 未提供
排除标准
- •Unwilling or unable to use an acceptable method to avoid pregnancy
- •Uncontrolled or significant cardiovascular disease, including prolonged QTc interval
- •History of significant bleeding disorder, unrelated to CLL
- •Prior concurrent malignancy
- •Drugs that generally accepted to have the risk of causing Torsades de Pointes
- •Autoimmune hemolytic anemia requiring therapy or transfusion support
- •Autoimmune thrombocytopenia requiring steroid therapy or transfusion support
- •Richter's Syndrome
- •Transformation to prolymphocytic leukemia
研究组 & 干预措施
Cohort #1
Experimental
干预措施: Dasatinib (Drug)
Cohort #1
Experimental
干预措施: Combination of Bendamustine + Dasatinib (Drug)
Cohort #2
Experimental
干预措施: Dasatinib (Drug)
Cohort #2
Experimental
干预措施: Combination of Bendamustine + Dasatinib (Drug)
结局指标
主要结局
Determine the maximum tolerated dose (MTD) as assessed by measuring dose limiting toxicities (DLT) at each dosing level
时间窗: From initial dose to the end of three cycles of treatment at each dosing level. Each cycle is 28 days, so approximately 91 days
次要结局
- The effects of treatment on various biological correlates will also be assayed(From initial dose to the end of six cycles of treatment. Each cycle is 28 days, so approximately 175 days)
- All response evaluable subjects Cohorts #1 and #2 are assessed for overall response rate(s): complete remission (CR); CR with incomplete marrow recovery (CRi); partial remission (PR); for progressive disease (PD) or stable disease (SD)(From initial dose to the end of six cycles of treatment. Each cycle is 28 days, so approximately 175 days)
研究者
研究点 (1)
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