KCT0002068招募中未知
A Phase IV Study to Evaluate Efficacy and Safety of Imatinib (Glinib®)600mg/day Depending on Early Molecular Responses in Newly Diagnosed Patients with Chronic Myeloid Leukemia in Chronic Phase
Dong-A ST0 个研究点目标入组 150 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •at the age of 18 or more
- •newly diagnosed within three months as a Chronic Myeloid Leukemia
- •with positive Philadelphia chromosome and appearance of BCR-ABL transcript
- •with 0 - 2 of ECOG Performance Status
- •with normal renal function
- •with normal hepatic function
- •able to understand and decide to involve the study
排除标准
- •history of radiation therapy for more than 25% of bone marrow due to other malignant diseases
- •history of other clinically relevant malignant tumors
- •with bleeding disorders which are not related to leukemia
- •evidence of clinically relevant cardiac dysfunction
- •with severe disease which cannot be regulated by other organs
- •a previous administration of Imatinib more than a week prior to the first dose.
- •participation in other drug study(eg. intervention trial) within 30 days prior to the screening visit
- •HIV-infected
- •females with pregnancy, childbearing or lactating potential
- •other reasons determined by investigators
研究者
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