NCT02317159Unknown4 期
Efficacy and Safety of Imatinib Mesylate as First-line Treatment for the Patients With Chronic Phase of Chronic Myeloid Leukemia
Cttq0 个研究点目标入组 90 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 主要终点
- major molecular response
研究概览
简要总结
This is a efficacy and safety study of imatinib Mesylate Capsule as First line treatment in patients with chronic phase of Chronic Myeloid Leukemia.
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
- •The new diagnosis of CML patients in six months；
- •No proof of extra-medullary infiltration of leukemia；
- •ECOG PS score：0-2；
- •Hepatic and renal functions are normal，Serum bilirubin≤1.5*ULN, serum ALT and AST≤2.5*ULN, serum Cr≤1.5*ULN;
- •Do not receive the treatment of anti-CML；
- •Subjects signed informed consent form in line with GCP requirements。
排除标准
- •Pregnant or lactating women；
- •Received TKIs any time before；
- •Failure to control systemic infection or multiple organ failure；
- •According to the investigator's judgment, there are concomitant diseases with a serious safety hazard or affect the patients completed the study；
- •Being diagnosed with other malignancies in the prior 12 months；
- •Have a history of neurological or psychiatric disorders, including epilepsy or dementia；
- •Known or suspected allergy to imatinib；
- •BSA≤1.5m2；
- •Using other experimental drugs or participating in other clinical trials in the prior one months。
研究组 & 干预措施
imatinib，Capsule
Experimental
400mg imatinib qd
干预措施: Imatinib (Drug)
结局指标
主要结局
major molecular response
时间窗: 2 years
the rate of major molecular response in two years
次要结局
- over survival(2 years)
- complete cytogenetics response(1 years)
- progress free survival(2 years)
研究者
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