NCT01409070已完成不适用
Head to Head Comparison of Azacitidine and Decitabine in Myelodysplastic Syndrome: Retrospective, Multicenter Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
In Myelodysplastic syndrome, epigenetic treatments such as Azacitidine and Decitabine have been highlighted in phase 3 studies. However, as the 1st line treatment, it has not been evaluated the head to head comparison of two drugs. This study is a retrospective study to compare the efficacy of two drugs.
详细描述
Among 300 MDS patient, 200 of them have been taking Azacitidine and 100 of them have been taking Decitabine. Medical chart of these patients will be reviewed to assess the efficacy and safety between two agents.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed MDS by bone marrow examination
- •Receiving azacitidine and decitabine as a first line chemotherapy
- •Adequate hepatic, cardiac, and renal function
排除标准
- •Previously treated with another anti-cancer therapy due to MDS
- •Not available for clinical information
结局指标
主要结局
Response rate
时间窗: 6 months
Compare Azacitidine and Decitabine's treatment response rate in MDS patients
次要结局
- Efficacy(6 months)
- Survival rate(6 months)
- Number of participants with non-hematologic toxicities(6 months)
- infection rate(6 months)
研究者
Inho Kim
Professor
Seoul National University Hospital
研究点 (1)
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