NCT04328298招募中不适用
French Register Of Patients With Hemopathy Eligible For CAR-T Cell Treatment (DESCAR-T)
The Lymphoma Academic Research Organisation36 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2019年12月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 36
- 主要终点
- overall survival from eligibility
研究概览
简要总结
This study is a registry including prospective and retrospective data on all patients who have been presented in a Multidisciplinary tumor board or RCP to be eligible for CAR-T cell treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 0 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Retrospective inclusion :
- •Patient treated with CAR-T from 1 July 2018 under temporary authorization (ATU) or covered by French health insurance system (under post-ATU or MA) in a qualified center before activation of this register in this center
- •If the patient is alive, the patient has been informed of the collection and use of their data, and the patient has not opposed this use. If the patient has died, the patient did not opposed the use of their data while alive
- •Prospective inclusion :
- •Patient eligible for a treatment with CAR-T for an hematological malignancy which is covered by French health insurance (for ATUs / post-ATUs or MA), or as part of a clinical trial with the same indication, after the activation of this register in this center.
- •Patient whose CAR-T indication has been validated during a multidisciplinary tumor board (RCP) of a qualified center, according to the ministerial order of 8 August 2019
- •Patient deemed eligible for a treatment with CAR-T after a medical exam performed in a qualified center according to the ministerial order of 8 August 2019
- •If the patient is alive, the patient has been informed of the collection and use of their data, and the patient has not opposed this use. If the patient has died, the patient did not opposed the use of their data while alive.
排除标准
- •Patient not registered with the social security in France
结局指标
主要结局
overall survival from eligibility
时间窗: 15 years
Progression free survival
时间窗: 15 years
Overall survival from administration
时间窗: 15 years
complete response rate
时间窗: 15 years
Duration of response
时间窗: 15 years
Delays between patient eligibility and CAR-T treatment
时间窗: 15 years
次要结局
未报告次要终点
研究者
研究点 (36)
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