EUCTR2013-000018-39-AT进行中（未招募）1 期
Clinical trial for the treatment of acute myeloid leukemia in children and adolescents - AML-BFM 2012
Gesellschaft für Pädiatrische Onkologie und Hämatologie (GPOH gGmbH)0 个研究点目标入组 625 人开始时间: 2016年3月10日最近更新:
适应症
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
- 625
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
- •diagnosis of AML (according to WHO classification 2008)
- •Acute leukemia with mixed line assignment and myeloid dominance (MPAL; according to WHO classification 2008: included dominant myeloid biphenotypic leukemia, and acute undifferentiated leukemia (AUL))
- •Age 0 to 18 years old
- •Consent for study participation and for data processing and data dissemination
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 625
- •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 with acute promyelocytic leukemia / AML with t (15, 17); PML / RARA
- •pre-existing conditions / syndromes which preclude treatment
- •Patients with trisomy 21 and ML-DS and / or transient myeloproliferative syndrome (reference to the TMD-prevention study or the ML-DS 2006 Study)
- •Acute leukemias bilineäre
- •Secondary acute myeloid leukemia observation patients
- •refusal of treatment
- •Participation in another clinical trial, the Invention could affect the questions of this study
- •Pregnancy
- •Lactation
- •Hypersensitivity to clofarabine
- •patients of reproductive age who reject an effective pregnancy prevention
- •previous treatment with cytostatic drugs for more than 14 days
研究者
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