EUCTR2012-003032-22-FI进行中(未招募)不适用
ALL SCTped 2012 FORUMAllogeneic Stem Cell Transplantation in Children and Adolesecents with Acute Lymphoblastic Leukaemia
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 1,000
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
- •Patients with ALL (except for patients with B-ALL) who fulfil the following criteria:
- •age at time of screening less than 18 years
- •indication for allogeneic HSCT
- •complete remission (CR) before SCT
- •written consent of the parents (legal guardian) and, if necessary,
- •the minor patient via Informed Consent Form”
- •no pregnancy
- •no secondary malignancy
- •no previous HSCT
- •HSCT is performed in a study participating centre
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1000
- •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
- •Patients who do not fulfil the inclusion criteria
- •Non Hodgkin-Lymphoma
- •ALL with extramedullary involvement with indication for TBI
- •CNS involvement at screening timepoint
- •Trisomy 21
- •The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian
- •No consent is given for saving and propagation of anonymous medical data for study reasons
- •Severe concomitant disease that does not allow treatment according to the protocol at the investigator’s discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)
- •Karnofsky / Lansky score < 50%
- •Subjects unwilling or unable to comply with the study procedures
研究者
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