National Longitudinal Cohort of Hematological Diseases (NICHE) - CART
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Long-term overall remission rate
研究概览
简要总结
This is a multicenter, ambispective, longitudinal, observational cohort study investigating CAR-T cell therapy in Chinese patients with hematological malignancies. A consortium of Phase IV clinical trials and real-world studies of Chimeric antigen receptors (CAR) T cell therapy will be established in China. Patient-level data from these studies will be collected to create a large real-world cohort. In addition, patients receiving CAR-T cell therapy for hematological malignancies identified from an existing hematology longitudinal cohort study, the National Longitudinal Cohort of Hematological Diseases (NICHE), will also be included in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinically diagnosed hematologic malignancies
- •Patients treated with CAR-T cell therapy
- •Signed the informed consent form
排除标准
- 未提供
结局指标
主要结局
Long-term overall remission rate
时间窗: 5 years
Proportion of the participants with an overall remission. To investigate the long-term efficacy of Chimeric antigen receptors (CAR) T cell therapy in Chinese patients with various hematological malignancies.
次要结局
- Complete remission rate(1 year, 2 years, 5 years)
- Partial remission rate(1 year, 2 years, 5 years)
- Long-term safety(5 years or more)