EUCTR2007-004517-34-CZ进行中（未招募）1 期
Allogeneic stem cell transplantation for children, adolescents and young adults with relapsed or refractory AML - AML SCT-BFM 2007
Hannover Clinical Trial Center GmbH0 个研究点目标入组 153 人开始时间: 2010年8月10日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 153
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
- •. Aged between 0-21 years
- •· Patients suffering from either refractory de novo AML or relapsed AML* or patients with very high risk AML in CR1**
- •· In sexually active patients two reliable contraception methods are used. This includes every combination of a hormonal contraceptive (such as injection, transdermal patch, implant, cervical ring) or of an intrauterine device (IUD) with a barrier method (e.g. diaphragm, cervical cap, or condom) or with a spermicide.
- •· Written informed consent of patient, parents or legal guardians
- •*AML is defined according to the WHO criteria in Tumours of Haematopoietic and Lymphoid Tissues, edited by ES Jaffe, NL Harris, H Stein, and JW Vardiman, page 75, IARC press,
- •Lyon 2001 (see also AML-BFM 2004 page 36 and current MRC 15 trial).
- •**As defined by the following aberrations: 12p, monosomy 7, t(4;11), t(5;11), t(6;11), t(6;9), t(7;12), t(9;22), t(8;16), t(10;11), and complex karyotype or WT1mut/FLT-ITD or AML as secondary malignancy (not MDS-related)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 145
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •. Severe renal impairment (GFR < 30% predicted for age)
- •· Pregnant or lactating females
- •· Current participation in another clinical trial
- •. Patients = 12 years old for Group 1 (BuCyMel”) (patients younger that 12 years continue to be included)
研究者
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