NCT03535753Unknown1 期
Safety and Efficacy Evaluation of Decitabine With R-GDP on Refractory or Relapsed NHL Patients
Beijing Immunochina Medical Science & Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
Assessment of the Safety and efficacy of Administering decitabin plus R-GDP to NHL patients
详细描述
RR NHL patients will be treated with decitabin plus R-GDP , safety and efficacy will be assessed.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed or refractory Non-Hodgkin's lymphoma(NHL) patiens.
- •Eastern Cooperative Oncology Group(ECOG) score 0-2
- •Expected survival >3 months
- •Measurable disease.
排除标准
- •Patients who needs treatment with immunosuppressive agents
- •Hematosepsis or Uncontrolled active infection
- •History of epilepsy or other CNS disease.
- •Active hepatitis B , hepatitis C or HIV infection or any other uncontrolled active infection.
- •Pregnancy or breast-feeding women.
- •Any uncontrolled medical disorders that the researchers considered are not suitable to participate the clinical trial.
- •Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluatio
研究组 & 干预措施
Decitabine and R-GDP
Experimental
ALL patients will be treated with Decitabine and R-GDP
干预措施: Decitabine and R-GDP (Drug)
结局指标
主要结局
OS
时间窗: 2 years
Overall survival
次要结局
未报告次要终点
研究者
研究点 (1)
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