NCT00171899已完成4 期
Study Comparing Standard Dose and High-dose Imatinib Mesylate in Patients With Chronic Phase Ph+ CML
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percent of patients achieving major molecular response at baseline and at last visit
研究概览
简要总结
The study will assess the role of high-dose imatinib mesylate, in patients who have taken imatinib mesylate for at least 1 year at the standard dose, in achieving a major molecular response (a measure of the level of chronic myelogenous leukemia) versus the standard dose.
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
- •Chronic myelogenous leukemia with Philadelphia chromosome
- •18 years and older
- •Patients must have been taking imatinib mesylate standard dose for at least 12 months and have achieved a complete cytogenetic response but not a major molecular response.
排除标准
- •Patients with cardiac problems such as congestive heart failure, or myocardial infarction within the last 6 months
- •Patients with an uncontrolled medical disease such as uncontrolled diabetes, chronic renal (kidney) disease or active uncontrolled infection.
- •Patients with other current primary malignancy or malignancy requiring active intervention
- •Other protocol defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
STI571
Experimental
干预措施: imatinib mesylate (Drug)
结局指标
主要结局
Percent of patients achieving major molecular response at baseline and at last visit
次要结局
- Complete cytogenetic response at baseline and at last visit
- Disease progression-free survival
- Overall survival
- Safety: adverse events and lab parameters, vital signs, physical exam, electrocardiogram, concomitant medications
- Quality of Life assessment at baseline, last visit
研究者
研究点 (1)
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