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

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study for Quality Of Life and Drug Use Assessment in Patients With CAR-T Cells

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

Intervention / Treatment
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* Other: Semi-structured interviews and self-administered questionnaires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with diffuse large B-cell lymphoma treated with CART-cells<br> | Other: Semi-structured interviews and self-administered questionnaires<br>* 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 therapies including herbal medicine. Seven self-administered questionnaires will be completed, concerning quality of life, Assessment of Cancer Treatment-Lymphoma, Beliefs about Medicines, Brief Illness Perception, satisfaction with medication, perceived social support scale, and on Health Literacy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Mean quality of life score using the EORTC-QLQ C30 questionnaire | Self-administered questionnaire EORTC-QLQ C30 (European Organisation for Research and Treatment of Cancer), developed to assess the quality of life of cancer patients, with 30 items. Score ranges from 0 (the worse) to 100 (the best). | Inclusion (the day before lymphodepletion chemotherapy), Month 3 and Month 6 after the administration of CART-T cells | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAR-T cells, Quality of life, drug use