Long-Term Follow-up Protocol for Subjects Treated With JCAR015
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Proportion of patients with adverse events
研究概览
简要总结
This study will provide long-term follow-up for patients who have received treatment with JCAR015 in a previous clinical trial. In this study, patients will be followed for up to 15 years after their last dose of JCAR015 for evaluation of delayed adverse events, presence of persisting JCAR015 vector sequences, and survival.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Proportion of patients with adverse events
时间窗: Every year for up to 15 years post-treatment
Proportion of patients with detectable JCAR015 vector sequences during first 5 years post-treatment
时间窗: Every 6 months for the first 5 years post-treatment
Proportion of patients with detectable JCAR015 vector sequences between 5 and 15 years post-treatment
时间窗: Every year from 5 years post-treatment to up to 15 years post-treatment
Survival
时间窗: Up to 15 years
次要结局
未报告次要终点