ISRCTN38648181已完成不适用
Randomised induction and post-induction therapy in adult patients (less than or equal to 60 years of age) with acute myelocytic leukaemia (AML) or refractory anaemia with excess of blasts (RAEB, RAEB-t) with IPSS score greater than or equal to 1.5
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)0 个研究点目标入组 800 人开始时间: 2005年12月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 18 - 60 years (inclusive)
- •2. Subjects with a cytopathologically confirmed diagnosis of:
- •2.1. AML (M0-M2 and M4-M7, FAB classification), or
- •2.2. With refractory anaemia with excess of blasts (RAEB) or refractory anaemia with excess of blasts in transformation (RAEB-t) with an IPSS score of greater than or equal to 1.5
- •3. Patients with therapy-related AML/RAEB/RAEB-t are eligible provided they have not received chemotherapy during the past 6 months. Also patients with biphenotypic leukemia may be included.
- •4. Subjects with a secondary AML progressing from antecedent myelodysplasia are eligible. Antecedent MDS refers to a condition of at least 4 month duration
- •5. World Health Organization (WHO) performance status less than or equal to 2
- •6. Written informed consent
排除标准
- •1. Prior chemotherapy within 6 months of study entry
- •2. Relapse of AML or MDS after induction chemotherapy
- •3. Prior stem cell transplant
- •4. Previous polycythemia rubra vera
- •5. Primary myelofibrosis
- •6. Blast crisis of chronic myeloid leukemia
- •7. AML-FAB type M3 or AML with cytogenetic abnormality t(1517) or AML with a PML/RAR alpha or a variant RAR alpha fusion gene
- •8. Impaired hepatic or renal function as defined by: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than 3 x normal value, bilirubin greater than 3 x normal value, serum creatinine greater than 3 x normal value (after adequate hydration), (unless these are most likely caused by AML organ infiltration)
- •9. Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, etc)
- •10. Cardiac dysfunction as defined by: myocardial infarction within the last 6 months of study entry, or reduced left ventricular function with an ejection fraction less than or equal to 50% as measured by MUGA scan or echocardiogram (another method for measuring cardiac function is acceptable), unstable angina, unstable cardiac arrhythmias
- •11. Pregnancy
研究者
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