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临床试验/NCT04328298
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.

注册库
clinicaltrials.gov
开始日期
2019年12月19日
结束日期
2038年12月19日
最后更新
上个月
研究类型
Observational
性别
All

研究者

发起方
The Lymphoma Academic Research Organisation
责任方
Sponsor

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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