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临床试验/EUCTR2009-012758-18-DE
EUCTR2009-012758-18-DE进行中(未招募)不适用

A randomized multi-center treatment study (COALL 08-09) to improve the survival of children with acute lymphoblastic leukemia on behalf of the German Society of Pediatric Hematology and Oncology - COALL 08-09

niversitätsklinikum Hamburg-Eppendorf0 个研究点开始时间: 2010年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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

  • Children and adolescents aged 1 up to = 18 years with a confirmed diagnosis of acute B-precursor or T-cell leukemia
  • Parent’s or legal guardian’s written informed consent and child’s assent
  • Phase II: high risk ALL defined by MRD load. B-precursor ALL at day 29 = 10-4, T-ALL at day 43 = 10-3
  • Phase III: MRD positive B-progenitor ALL and T-ALL with MRD = 10-3 at day 29
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • ALL diagnosed as second malignancy
  • Cytostatical pre-treatment for more than 1 week
  • Prior severe disease that prohibit treatment according to the protocol
  • Patients with translocation t(9/22)
  • Pregnant or breastfeeding adolescents

研究者

发起方
niversitätsklinikum Hamburg-Eppendorf

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A randomized multi-center treatment study (COALL... | 临床试验