EUCTR2004-003739-30-AT进行中（未招募）1 期
Phase II Study on Gemtuzumab Ozogamicin in Combination with All-trans-Retinoic Acid, high-dose Cytarabine and Mitoxantrone in Patients with primary refractory acute myeloid leukemia [GO-A-HAM] - GO-A-HAM
niversitätsklinikum Ulm / University Clinical Center Ulm0 个研究点目标入组 84 人开始时间: 2005年9月28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
- 84
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
- •1.) acute myeloid leukemia defined according the WHO classification not responding to first induction therapy
- •2.) age 18-60 years
- •3.) written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.) acute promyelocytic leukemia
- •2.) uncontrolled infection
- •3.) transfusion-refractory thrombocytopenia
- •4.) pregnancy, breast-feeding, insufficient contraception
- •5.) participation in other controlled clinical trials
- •6.) organ insufficiency: kidneys, liver, lungs, heart
- •7.) severe neurological or psychiatrical condition interfering with informed consent
- •8.) No consent for the registration, storage and processing of data concerning the characteristics of the AML and the individual course
- •9.) performance status > grad 2 according the WHO classification
研究者
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