NCT03985007已完成2 期
Chidamide, Decitabine Combined With Priming IAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年1月1日最近更新:
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
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Remission Rate
研究概览
简要总结
This study is to investigate the therapeutic efficacy and side effect of chidamide, decitabine combined with priming IAG regimen for relapsed or refractroy acute myeloid leukemia
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed or refractory acute myeloid leukemia patients without severe complications such as active infections and bleedings; ECOG score less than 3.
排除标准
- •Inablity to tolerate inducton chemotherapy; life expectancy less than 1 month
研究组 & 干预措施
CDIAG
Experimental
Relapsed or refractroy acute myeloid leukemia patients reveive chidamide, decitabine combined with priming IAG regimen treatment.
干预措施: CDIAG regimen (Drug)
结局指标
主要结局
Remission Rate
时间窗: 1 month
Remission rate achieved after one-two couses induction therapy by CDIAG regimen
Overall survial
时间窗: 1 year
It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
次要结局
- Adverse events in hematological system(1 month)
- Adverse events in other organs or systems(1 month)
研究者
Sheng-Li Xue, MD
accociate professor
The First Affiliated Hospital of Soochow University
研究点 (1)
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