ISRCTN11571826已完成不适用
An open label randomised controlled study in elderly subjects with previously untreated acute myelogenous leukaemia, comparing treatment groups randomised to receive daunorubicin and cytarabine or daunorubicin, cytarabine and PSC-833
ovartis Pharma AG (Switzerland)0 个研究点目标入组 400 人开始时间: 2005年12月19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
- 400
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 greater than or equal to 60 years
- •2. Subjects who have a cytopathologically confirmed diagnosis of previously untreated AML (M0-M2 and M4-M7, FAB classification)
- •3. Subjects with secondary AML progressing from antecedent MDS are eligible if there has been no previous chemotherapy. Antecedent MDS is defined as any antecedent haematological disease of at least 4 months duration.
- •4. World Health Organization (WHO) performance status less than or equal to 2
- •5. Subjects have given written informed consent
排除标准
- •1. Cytopathologically confirmed central nervous system (CNS) infiltration. NB: in the absence of clinical suspicion of CNS involvement, lumbar puncture is not required.
- •2. Subjects have had previous Polycythemia Rubra Vera, primary myelofibrosis, are in blast cell crisis of chronic myeloid leukaemia or are M3 AML according to FAB classification
- •3. Subject has neurosensory toxicity greater than or equal to Grade 2 (NCIC Expanded CTC)
- •4. Subject has neurocerebellar toxicity greater than or equal to Grade 1 (NCIC Expanded CTC)
- •5. Subject is known to be positive for human immunodeficiency virus (HIV) type 1 antibody (testing to determine HIV antibody status is not necessary to be eligible)
- •6. Subject has impairment of hepatic or renal function as defined by the following baseline laboratory values:
- •6.1. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than or equal to 2.5 times IULN
- •6.2. Alkaline phosphatase greater than or equal to 2.5 times IULN
- •6.3. Serum total bilirubin greater than or equal to 1.5 times IULN
- •6.4. Serum creatinine greater than or equal to 1.5 times IULN after adequate hydration
- •7. Subject is currently receiving treatment with any of the agents listed in the protocol if treatment cannot be discontinued at the specified time relative to PSC-833 administration. All of the drugs listed are well substantiated to interact with cyclosporin A.
- •8. Subject has had major surgery within 2 weeks of study entry
- •9. Subject has received investigational therapy within 30 days of study entry
- •10. Subject has known hypersensitivity to cyclosporin A
- •11. Subject has received prior radiotherapy within 4 weeks of study entry
- •12. Subject is less than 5 years free of another primary malignancy with the exception of basal cell carcinoma of the skin and stage 1 cervical carcinoma
- •13. Subject has previously been treated with chemotherapy for AML
- •14. Subject has concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension etc.)
- •15. Subject has a psychological, intellectual or sensory dysfunction which is likely to impede their ability to understand and comply with study requirements
- •16. Subject had a myocardial infarction within the last 6 months, has symptomatic ischaemic heart disease, congestive heart failure or other uncontrolled coronary disease
研究者
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