NCT03436771终止不适用
Long-Term Follow-up Protocol for Subjects Treated With a CAR T-Cell Product on a Juno-Sponsored Clinical Trial
Juno Therapeutics, a Subsidiary of Celgene2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2018年2月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Proportion of patients with detectable viral vector sequences
研究概览
简要总结
This study will provide long-term follow-up for patients who have received treatment with a Juno CAR T-cell product in a Juno-sponsored clinical trial. In this study, patients will be followed for up to 15 years after their last dose of Juno CAR T cells for evaluation of delayed adverse events, presence of persisting CAR T-cell vector sequences, presence of replication-competent retrovirus (RCR) or lentivirus (RCL), 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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have received at least one dose of a Juno CAR T-cell product (listed above) in a Juno-sponsored clinical trial
- •Patients who have provided informed consent for the long-term follow-up study
排除标准
- •None. All patients who have previously received treatment with a Juno CAR T-cell product are eligible for this long-term follow-up study.
结局指标
主要结局
Proportion of patients with detectable viral vector sequences
时间窗: 15 years from last treatment
Proportion of patients with detectable RCR or RCL
时间窗: 15 years from last treatment
Proportion of patients with adverse events
时间窗: 15 years from last treatment
次要结局
- Overall survival(15 years from last treatment)
- Progression-free survival(15 years from last treatment)
研究者
研究点 (2)
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