NCT03027739Unknown2 期
CART-19 Cells For Patients With Minimal Residual Disease (MRD) Positive CD19+ Acute Lymphoblastic Leukemia
Fujian Medical University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Leukemia free survival
研究概览
简要总结
CART-19 cells has emerged as a powerful targeted immunotherapy, showing striking responses in highly refractory CD19+ acute lymphoblastic leukemia (ALL). This study aims to assess the safety and toxicity of CART-19 cells to patients who are refractory or at highest risk of relapse as defined by MRD+ status.
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
- 1 Year 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Aged between 1-60 years
- •Patients with MRD positive CD19+ ALL
- •Cardiac: Left ventricular ejection fraction ≥ 50%
- •Adequate renal and hepatic function
- •Performance status: Karnofsky ≥ 70%
排除标准
- •Pregnant or lactating females.
- •Any co-morbidity precluding the administration of CART-19 cells.
研究组 & 干预措施
Arm 1
Experimental
CART-19 cells treated
干预措施: CART-19 (Biological)
结局指标
主要结局
Leukemia free survival
时间窗: 1 year
次要结局
- Adverse events that are related to treatment(1 year)
研究者
Jianda Hu
Director of the department of Hematology
Fujian Medical University
研究点 (1)
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