NCT00732186撤回1 期
Phase Ib Study Evaluating the Safety and Exploring the Molecular and Cytogenetic Response of Combination Therapy With Dasatinib and Ipilimumab in Patients With Chronic or Accelerated Phase Chronic Myeloid Leukemia
Bristol-Myers Squibb2 个研究点 分布在 1 个国家开始时间: 2009年8月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- To evaluate the safety of ipilimumab in combination with dasatinib in CML patients with a loss of previously achieved major molecular response or a loss of previously achieved cytogenetic response to dasatinib
研究概览
简要总结
The purpose of the study is to assess the safety of ipilimumab and dasatinib combination therapy in patients with CML
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Ph+ CML on dasatinib therapy
- •Loss of cytogenetic or molecular response while on dasatinib therapy
- •On stable dose of dasatinib for a minimum of 12 weeks and with < 14 day interruption of treatment
排除标准
- •Blast crisis CML
- •Autoimmune disease
- •Uncontrolled or significant cardiovascular disease
结局指标
主要结局
To evaluate the safety of ipilimumab in combination with dasatinib in CML patients with a loss of previously achieved major molecular response or a loss of previously achieved cytogenetic response to dasatinib
时间窗: At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38
次要结局
- To explore whether molecular responses to combination therapy with ipilimumab and dasatinib correlate with immunologic responses(At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38)
- To evaluate the frequency of molecular response, complete cytogenetic response and an overall efficacy signal response rate(At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38)
- To explore the immunologic responses to combination therapy with ipilimumab and dasatinib(At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38)
研究者
研究点 (2)
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