NCT00219765终止1 期
Phase I/II Trial to Study the Dose, Tolerability and the Effectiveness of Imatinib in Combination With Daunorubicine and Cytarabine for Patients With Chronic Myelogenous Leukemia in Myeloid Acute Phase
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- To assess the tolerability and the effectiveness of imatinib in combination with daunorubicine and cytarabine and to determine the recommended dose of daunorubicine to be associated with cytarabine
研究概览
简要总结
The aim of this phase I/II trial is to determine the dose of daunorubicine to be associated with cytarabine and Imatinib for induction therapy in patients with chronic myelogenous leukemia in myeloid acute phase.
详细描述
Study design Imatinib: starting at day -3: 600mg/day; continuous administration In combination with cytarabine: continuous iv/24h: 100mg/m² ; 7 days and daunorubicine: 4 levels
level 1: 0
level 2: 15mg/m² ; 3 days
level 3: 30mg/m² ; 3 days
level 4: 45mg/m² ; 3 days
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
- •CML Ph+ (assessed by cytogenetic or FISH)
- •Acute phase with ≥ 20% bone marrow blasts (M0 to M6 , excluding M3)
- •Age ≥ 18 year at inclusion
- •PS grade 0 to 2 (ECOG)
- •Adequate and organ function, defined as the following: total bilirubin <1.5x uln, sgpt <3x uln, creatinine <1.5x uln.
- •Informed consent signed up
排除标准
- •active malignancy other than CML or non-melanoma cancer of the skin
- •current treatment with another investigational agent
- •patients with grade 3/4 cardiac disease or any other serious concurrent medical condition.
- •patients who are pregnant or nursing. All patients of childbearing potential must practice effective methods of contraception while on study.
- •patients with mental illness or other condition precluding their ability to give informed consent or to comply with study requirements patients with performans status 3-4
结局指标
主要结局
To assess the tolerability and the effectiveness of imatinib in combination with daunorubicine and cytarabine and to determine the recommended dose of daunorubicine to be associated with cytarabine
次要结局
- - To evaluate the survival without progression, the survival without event, the overall survival, the hematologic, cytogenetic and molecular responses at various check points.
- - To evaluate duration of responses and failure to respond
研究者
研究点 (2)
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