NCT00358644已完成2 期
A Phase II Study of Decitabine For the Front-line Treatment of Older Patients With Acute Myeloid Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 55
- 主要终点
- Complete Response = Morphologic Complete Remission (mCR)
研究概览
简要总结
The purpose of this study is to estimate the rate of complete remission, as well as overall survival, in older patients with Acute Myeloid Leukemia (AML).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of AML or transformed from myelodysplastic syndrome (MDS) within 2 weeks of study enrollment.
- •Ineligible to receive intensive chemotherapy for their disease.
- •Have not received any chemotherapy within 4 weeks of study enrollment and must have recovered from any treatment-related toxicities.
排除标准
- •Received previous treatment for AML.
- •Previously received Vidaza.
- •Received any other investigational agents within 30 days of first dose of study drug.
- •Uncontrolled intercurrent illness.
- •Had radiotherapy within 14 days prior to study enrollment.
研究组 & 干预措施
1
Experimental
干预措施: Decitabine (Drug)
结局指标
主要结局
Complete Response = Morphologic Complete Remission (mCR)
时间窗: 1 year
次要结局
未报告次要终点
研究者
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