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

Civil Hospices of Lyon

Status

Enrolling

Conditions

Patients With Diffuse Large B-cell Lymphoma Treated With CART-cells

Treatments

Other: Semi-structured interviews and self-administered questionnaires

Study type

Observational

Funder types

Other

Identifiers

NCT04914091

69HCL20_1182

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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