Clinical Study of Genetically Modified Dendritic Cells Combining to Cytokine-Induced Killer Cells for Patients With Relapse Acute Leukemia After Allo-HSCT
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
Allogeneic hematopoietic cell transplantation(Allo-HSCT) is currently an effective treatment for Acute leukemia (AL). Relapse after transplantation, being a main obstacle for patient survival, is so far treated by second transplantation and donor leukocyte infusion (DLI), which seems to have high risk and low survival. Need for a new medication on relapse is urgent. The immunotherapy using Dendritic cells (DCs) combined with cytokine induced killer (CIK) cells holds promise for the adjuvant treatment of AL to eradicate or control residual disease. This randomized study was conducted to evaluate the feasibility and effective of genetically modified DCs combining to CIK immunotherapy in relapse AL after allo-HSCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 61 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AL patients according to the WHO criteria
- •expected survival duration of more than 3 months
- •age between 8 and 61years
排除标准
- •underlying autoimmune disease
- •positive serology for HIV infection
- •chronic active hepatitis
结局指标
主要结局
Overall survival
时间窗: up to 3 years
次要结局
- Gvhd incidence(100 days)