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临床试验/DRKS00022788
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

发起方
GPOH gemeinnützige GmbH AML-BFM Studienzentrale

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