To Observe and Evaluate the Efficacy and Safety of Inaticabtagene Autoleucel Injection in the Treatment of Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia in Adults in the Real World
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- overall survival
研究概览
简要总结
This clinical trial is a non-interventional, observational, multicenter, post-marketing real-world study to evaluate the efficacy and safety of Inaticabtagene Autoleucel Injection in Chinese adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
详细描述
The study is a non-interventional, observational, multicenter, post-marketing real-world study, and its objective is to evaluate the efficacy and safety of Inaticabtagene Autoleucel Injection in the treatment of Relapsed or Refractory acute lymphoblastic leukemia. The study consists of screening period including leukapheresis, treatment period, and follow-up period (2 years at most).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia;
- •Patients deemed eligible for receiving commercial Inaticabtagene Autoleucel injection treatment as determined by the investigator;
- •Patients voluntarily participate in this study and sign an informed consent form. For patients lacking full legal capacity, informed consent must be obtained from their legal guardian
排除标准
- 未提供
结局指标
主要结局
overall survival
时间窗: 2 years
OS is defined as the time from the start date of Inaticabtagene Autoleucel Injection infusion to the date of death due to any cause.
次要结局
未报告次要终点