EUCTR2010-019710-24-IT进行中（未招募）1 期
A Randomized Study to Evaluate the Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia in Elderly Patients (QoLESS AZA-AMLE) - QoLESS-AZA-AMLE
ASSOCIAZIONE QOL-ONE0 个研究点目标入组 95 人开始时间: 2010年6月21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
- 95
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. Age 61 years or more 2. Newly diagnosed AML with > 30% myeloid marrow blasts, either ``de novo`` or evolving from a MDS not previously treated with chemotherapeutic agents. 3. Absence of central nervous system involvement 4. No contraindications for intensive chemotherapy, defined as: a) prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range; b) a creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related; c) a PS score of > 2; d) uncontrolled severe infection. 5. Informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Age = 60 years 2. Newly diagnosed AML with < 30% myeloid marrow blasts 3. Previously treated AML 4. Central nervous system involvement 5. Prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range; 6. A creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related; 7. A PS score of > 2; 8. Uncontrolled severe infection
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