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2019年12月19日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Hematopathology Eligible or CAR-t Cell Treatment
- 发起方
- The Lymphoma Academic Research Organisation
- 入组人数
- 5000
- 试验地点
- 36
- 主要终点
- overall survival from eligibility
- 状态
- 招募中
- 最后更新
- 上个月
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.
研究者
入排标准
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
研究点 (36)
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