EUCTR2011-000440-22-DK进行中（未招募）1 期
MULTICENTER TRIAL ESTIMATING THE PERSISTANCE OF MOLECULAR REMISSION IN CHRONIC MYELOID LEUKAEMIA AFTER STOPPING TKI - EURO-SKI
niversity of Heidelberg0 个研究点目标入组 500 人开始时间: 2014年3月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •CML in CP under treatment with TKI in first line or in second line because of toxicity to first line TKI or with TKI in combination
- •Duration of TKI treatment before enrolment at least 3 years
- •Complete molecular remission (CMR4 (= 0.01% on IS) for at least one year; at least three PCR-results with CMR4 within the last year (± 2 months) before study entry
- •Before inclusion confirmation of CMR through a EUTOS-CMR laboratory
- •Both sexes but fertile women only if using effective contraceptive
- •Health insurance coverage
- •18 years or older
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •Under 18 years old
- •Hospitalized patients without ability to give informed consent
- •Adults under law protection or without ability to assent
- •Previous or planned allogeneic stem cell transplantation
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