ACTRN12610000641099招募中2 期
A single arm pilot study of azacitidine in myelodysplastic syndrome / acute myeloid leukaemia, with eltrombopag support for thrombocytopenia
Peter Mac Callum Cancer Centre0 个研究点目标入组 25 人开始时间: 2010年8月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
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
- Non-randomised 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
- •Patients with low platelet count (<=150 x109/L) and in addition disease diagnosis of either MDS (by World Health Organization Criteria, those with refractory anemia with high blast counts and refractory anemia with ringed sideroblasts to also have at least one clinically significant cytopenia), nonproliferative Chronic Myelomonocytic Leukaemia (CMML) or low marrow blast count AML not suitable for induction chemotherapy; 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
- •Subjects with the diagnosis acute promyelocytic leukaemia; Prior treatment with 5-azacitidine or any other methyl-transferase inhibitor, eltrombopag, romiplostim, or other Trombopoietin T (TPO)-receptor agonist;AML or MDS requiring cytoreductive therapy (eg hydroxyurea, ara-c, thioguanine etc) in the month prior to study entry; known pro-thrombotic condition; history of Ischaemic neurological event (Transient Ischaemic Attack (TIA) or stroke) within the preceding 2 years;active or uncontrolled infections
研究者
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