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Recruiting NCT04914091

Quality Of Life and Drug Use in Patients With CAR-T Cells

Trial Parameters

Condition Patients With Diffuse Large B-cell Lymphoma Treated With CART-cells
Sponsor Hospices Civils de Lyon
Study Type OBSERVATIONAL
Phase N/A
Enrollment 70
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-03-31
Completion 2033-01-31
Interventions
Semi-structured interviews and self-administered questionnaires

Brief Summary

CAR-T cells are a major therapeutic innovation in the management of patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) in 3rd line or more. Kymriah® and Yescarta® are the first CAR-T with Marketing Authorization and coverage by the French Health Insurance. Their clinical interest has been demonstrated in non-comparative phase 1-2 trials. The non-comparative design of the pivotal trials, the lack of data on patients' quality of life and drug consumption, as well as the very high cost of CAR-T (about € 320,000 for one treatment) warrant further studies. This prospective non-comparative study aims to describe in real life the quality of life of patients treated with CAR-T cells, real world drug use and patients' experience feedback.

Eligibility Criteria

Inclusion Criteria: * Over 18 years old * Eligible for treatment with CAR-T cells (outside any clinical trial) in an indication of DLBCL and for which treatment is scheduled * Follow-up in the Hematology department of the Hospices Civils de Lyon * Without major psychiatric disorder likely to interfere with the conduct of the study, in the opinion of the investigator * Having given his non-opposition to participate in the study. Exclusion Criteria: * In an institution * Under legal protection

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