ACTRN12616001394437终止2 期
Total body irradiation vs non-total body irradiation myeloablative conditioning regimen for allogeneic stem cell transplantation in children and adolescents with acute lymphoblastic leukaemia.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 21
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- o limit 至 18 Years（—）
- 性别
- All
入选标准
- •All patients with ALL (except for patients with mature B-ALL) who fulfil the following criteria:
- •- Age at diagnosis less than or equal to 18 years. Age at HSCT less than or equal to 21 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
排除标准
- •- Non Hodgkin-Lymphoma
- •- 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;
- •Renal impairment (< 30% of normal glomerular filtration rate)
- •Severe pulmonary, hepatic or cardial impairment due to toxicity or infection
- •- Karnofsky / Lansky score < 50%
- •- Subjects unwilling or unable to comply with the study procedures
研究者
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