Quality Of Life and Drug Use in Patients With CAR-T Cells
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Semi-structured interviews and self-administered questionnaires.
- Who it may be relevant to
- Registry conditions: Patients With Diffuse Large B-cell Lymphoma Treated With CART-cells. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Study for Quality Of Life and Drug Use Assessment in Patients With CAR-T Cells
Overview
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.
Interventions
- Other Semi-structured interviews and self-administered questionnaires
Interviews and questionnaires will be performed before administration of CAR-T cells, 3 month after and 6 month after, and will last 60 minutes each time. Semi-structured interview using pre-established questionnaires will be completed with a hospital pharmacist, concerning the patient's perception of his family, socio-professional environment, his knowledge of his illness and his treatment, the consumption of prescribed drugs outside the hospital, self-medication, complementary alternative ther
Primary outcome measures
- Change of Mean quality of life score using the EORTC-QLQ C30 questionnaire [Time frame: Inclusion (the day before lymphodepletion chemotherapy), Month 3 and Month 6 after the administration of CART-T cells]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hospices Civils de Lyon -Groupement Hospitalier Sud Service pharmaceutique, Unité de Pharm — Pierre-Bénite
Identifiers
NCT: NCT04914091 · 69HCL20_1182