ISRCTN77039377已完成3 期
Randomised induction and post induction therapy in older patients (greater than or equal to 61 years of age) with Acute Myelocytic Leukaemia (AML) and Refractory Anaemia with Excess of Blasts (RAEB, RAEB-t)
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
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 800
研究概览
简要总结
- 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19776405 2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20103782
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age 61 years or more
- •2. Subjects with a cytopathologically confirmed diagnosis of AML (M0-M2 and M4-M7, FAB classification), or with Refractory Anaemia with Excess of Blasts (RAEB) or Refractory Anaemia with Excess of Blasts in transformation (RAEB-t) with an International Prognostic Scoring System (IPSS) score of greater than or equal to 1.5
- •3. Subjects with a secondary AML progressing from antecedent Myelodysplasia (MDS) and biphenotypic leukemia are eligible. Antecedent MDS refers to any antecedent haematological disease of at least four month duration
- •4. World Health Organisation (WHO) performance status less than or equal to two
- •5. Written informed consent
排除标准
- •1. Previous induction treatment for AML/MDS
- •2. Prior chemotherapy within six months of study entry
- •3. Previous polycythemia rubra vera
- •4. Primary myelofibrosis
- •5. Blast crisis of chronic myeloid leukemia
- •6. AML-FAB type M3 or AML with cytogenetic abnormality t(1517) translocation
- •7. Impaired hepatic or renal function as defined by:
- •a. Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) greater than 25 x normal value
- •b. Bilirubin greater than 2 x normal value
- •8. Serum creatinine greater than 2 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:
- •10.1. myocardial infarction within the last six months of study entry, or
- •10.2. reduced left ventricular function with an ejection fraction less than or equal to 50% as measured by Multiple Gated Acquisition (MUGA) scan or echocardiogram (another method for measuring cardiac function is acceptable)
- •11. Unstable angina
- •12. Unstable cardiac arrhythmias
研究者
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