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

Recruiting now

Conditions studied: Patients With Diffuse Large B-cell Lymphoma Treated With CART-cells

In brief

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.

Key facts

Study ID: NCT04914091
Run by: Hospices Civils de Lyon
People needed: 70
Starts: 2021-03-31
Expected to finish: 2033-01-31
Last updated by the study team: 2026-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

In an institution
Under legal protection

Where it is running

Hospices Civils de Lyon -Groupement Hospitalier Sud Service pharmaceutique, Unité de Pharmacie Clinique Oncologique — Pierre-Bénite, France (enrolling)

Full record on ClinicalTrials.gov

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