NCT00219752已完成2 期
Phase II Trial to Study the Tolerability and the Effectiveness of Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase With Age More Than 70, Diagnosis of CML is Being Performed Within 1 Year
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Quality of life
研究概览
简要总结
The aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in patients with chronic myelogenous leukemia in chronic phase with age more than 70, diagnosis of cml is being performed within 1 year. Quality of life will be carefully assessed.
详细描述
Patients will received Imatinib at a dose of 400mg daily. Tolerability and quality of life will be assessed Secondary objectives are : to evaluate the survival without progression, the survival without event, the overall survival, the hematologic, cytogenetic and molecular responses at various check points.
Duration of responses and failure to respond will be evaluated.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CML Ph+ (assessed by cytogenetic or FISH)
- •Chronic phase with less than 5% bone marrow blasts
- •Diagnosis within 12 months
- •Age ≥ 70 year at inclusion
- •PS grade 0 to 2 (ECOG)
- •Mini mental status more than 25
- •Hydroxyurea optional before Imatinib
- •Adequate end organ function, defined as the following: total bilirubin <1.5x uln, sgpt <3x uln, creatinine <1.5x uln.
排除标准
- •patients who cannot sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital
- •Mini mental status ≤ 25
- •patients who are not able to adequately take the study drug
- •Age less than 70 y
- •accelerated or blastic phase
- •previous therapy with imatinib or interferon
- •HIV positivity
结局指标
主要结局
Quality of life
Tolerability
次要结局
- . the survival without progression
- . the survival without event
- . the overall survival
- . the hematologic cytogenetic and molecular responses at various check points.
- . duration of responses and failure to respond
研究者
研究点 (2)
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