EUCTR2007-004517-34-DE进行中（未招募）1 期
Allogeneic stem cell transplantation for children, adolescents and young adults with relapsed or refractory AML Multi Center Therapy Concept - AML SCT-BFM 2007
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
入选标准
- •Aged between 0-21 years
- •Patients suffering from either refractory de novo AML or relapsed AML or patients with high risk AML in CR1 (As defined by AML as secondary malignancy (not MDS-related) or with high-risk cytogenetic aberrations like the following: 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), complex karyotype or WT1mut/FLT-ITD).
- •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
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 150
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3
- •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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