NCT00866736已完成2 期
A Phase II Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia
Kanto CML Study Group1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2009年3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
- 65
- 试验地点
- 1
- 主要终点
- rate of Major Molecular Responses (MMR) in chronic phase chronic myeloid leukemia subjects
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and the safety of dasatinib in subject with chronic phase chronic myeloid leukemia(CML) who are either resistant to or intolerant of imatinib mesylate.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Written Informed Consent
- •Subjects with chronic phase chronic myeloid leukemia (CML)
- •Subjects resistant/intolerant to imatinib
- •Subjects presenting:
- •ECOG performance status (PS) score 0-2
- •Adequate hepatic function
- •Adequate renal function
- •Adequate lung function
排除标准
- •Concurrent malignancy other than CML
- •Women who are pregnant or breastfeeding
- •Concurrent pleural effusion
- •Uncontrolled or significant cardiovascular disease
- •A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy.
- •Prior therapy with dasatinib
- •Subjects with T315I and/or F317L BCR-ABL point mutations
研究组 & 干预措施
dasatinib
Experimental
干预措施: dasatinib (Drug)
结局指标
主要结局
rate of Major Molecular Responses (MMR) in chronic phase chronic myeloid leukemia subjects
时间窗: at 12 months
次要结局
- progression free survival(2 year)
- efficacy on patients with BCR-ABL point mutations(2 year)
- safety after treatment with dasatinib(2 year)
- rate of Complete Cytogenetic Response(CCyR)(2 year)
- rate of Complete Hematologic Response (CHR)(2 year)
研究者
研究点 (1)
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