NL-OMON25298已完成不适用
An open label randomized 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 AGCH-4002 BaselSwitzerland0 个研究点目标入组 400 人开始时间: 待定最近更新:
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
B. van der Holt, B. Löwenberg, A.K. Burnett, W.U. Knauf, J. Shepherd, P.P. Piccaluga, G.J. Ossenkoppele, G.E.G. Verhoef, A. Ferrant, M. Crump, D. Selleslag, M. Theobald, M.F. Fey, E. Vellenga, M. Dugan and P. Sonneveld. The value of the MDR1 reversal agent PSC-833 in addition to daunorubicin and cytarabine in the treatment of elderly patients with previously untreated acute myeloid leukemia (AML), in relation to MDR1 status at diagnosis. Blood, in press. 2005
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Age >= 60 years;
- •2. Subjects who have a cytopathologically confirmed diagnosis of previously untreated AML (M0-M2 and M4-M7, FAB classification);
排除标准
- •1. Cytopathologically confirmed 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;
研究者
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