Clinical Study of Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment for Adult High-risk Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Relapse rate within 2 years
研究概览
简要总结
To observe the efficacy and side effects of autologous hematopoietic stem cell transplantation combined with CD19-CART for adult acute lymphoblastic leukemia, and to evaluate the safety and efficacy of this regimen in the treatment of acute lymphoblastic leukemia.
详细描述
To observe the efficacy and side effects of autologous hematopoietic stem cell transplantation combined with CD19-CART for adult acute lymphoblastic leukemia, and to evaluate the safety and efficacy of this regimen in the treatment of acute lymphoblastic leukemia.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with high-risk acute B-lymphoblastic leukemia
- •Complete remission was achieved after induction chemotherapy, and autologous CD19-CAR-T was successfully prepared
- •Eligible for autologous hematopoietic stem cell transplantation
- •No major organ dysfunction
排除标准
- •Combined with malignant tumors of other organs
- •With a serious infection that is not under control
- •Syphilis, AIDS, hepatitis B, hepatitis C, any one of them positive
- •Patients who have had an allergic reaction to the drugs used in this study or similar drugs
- •Other patients deemed unsuitable for inclusion by the investigators
研究组 & 干预措施
Autologous hematopoietic stem cell transplantation combined with CD19-CART
干预措施: Autologous hematopoietic stem cell transplantation combined with CD19-CART (Biological)
结局指标
主要结局
Relapse rate within 2 years
时间窗: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
次要结局
- Overall survival rate(Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation)
- Non-relapse mortality(Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation)
- Progression-free survival(Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation)
- Incidence of infection(Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation)