ACTRN12610000271000已完成2 期
A Randomised Phase II study comparing the efficacy of 5azacitidine alone versus combination therapy with lenalidomide and 5azacitidine in patients with higher risk myelodysplastic syndromes (MDS) and low marrow blast count acute myeloid leukaemia (AML).
Australasian Leukaemia and Lymphoma Group0 个研究点目标入组 160 人开始时间: 2010年4月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Disease diagnosis of either MDS (by World Health Organisation criteria, those with refractory anaemia and Refractory Anaemia with Ringed Sideroblasts to also have at least one clinically significant cytopenia), nonproliferative Chronic Myelomonocytic Leukaemia (CMML) or low marrow blast count AML; Eastern Cooperative Oncology Group (ECOG) 2 or less with life expectancy at least 3 months, adequate contraception and adequate renal and hepatic function, written informed consent.
排除标准
- •Prior chemotherapy for MDS or AML except low dose cytarabine or hydroxyurea, any prior demethylating agent or immunomodulatory drug (including thalidomide or lenalidomide), prior diagnosis of cancer except with low risk of recurrence, significant renal, hepatic, cardiac or respiratory disease or severe active infection.
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