NCT04328298RecruitingNot Applicable
French Register Of Patients With Hemopathy Eligible For CAR-T Cell Treatment (DESCAR-T)
The Lymphoma Academic Research Organisation36 sites in 1 country5,000 target enrollmentStarted: December 19, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 5,000
- Locations
- 36
- Primary Endpoint
- overall survival from eligibility
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 0 Years to 99 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Patient not registered with the social security in France
Outcomes
Primary Outcomes
overall survival from eligibility
Time Frame: 15 years
Progression free survival
Time Frame: 15 years
Overall survival from administration
Time Frame: 15 years
complete response rate
Time Frame: 15 years
Duration of response
Time Frame: 15 years
Delays between patient eligibility and CAR-T treatment
Time Frame: 15 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (36)
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