DRKS00022788进行中(未招募)3 期
Clinical Trial for the treatment of acute myeloid leukaemia in children and adolescents - AML-BFM 2012
GPOH gemeinnützige GmbH AML-BFM Studienzentrale0 个研究点目标入组 164 人开始时间: 2021年3月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 164
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- one 至 18 Years(—)
- 性别
- All
入选标准
- •Diagnosis of an AML (It. WHO classification 2008)
- •Acute leukemia of ambiguous lineage (MPAL; It. WHO classifiction 2008: acute undifferenziated leukemia (AUL, bilineal leukemia; biphenotype leukemias, dominant myelogenous; lineage switch)
- •Ages 0 to 18 years
- •Informed consent for study participation and data handling
排除标准
- •Existing syndromes which exlude treatment
- •Patients with trisomy 21 and ML-DS and/or transient myeloproliferativem syndrome (link to the TMD-prevention study or the ML-DS 2006 study)
- •Patients with an acute promyeloblastic leukemia (APL), AML with t(15;17)
- •Treatment related AML
- •Refusal of treatment/ missing informed consent to treatment or protocol
- •Participation in another clinical trial with an intervention interfering with the aims of this trial
- •breast feeding
- •Known allergic reaction to the study drug
- •Patients of child-bearing age who decline a pregnancy test or refuse appropriate prevention of pregnancy.
- •Previous-therapy with cytostatistic medicines of more than 14 days.
研究者
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