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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with diffuse large B-cell lymphoma treated with CART-cells |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semi-structured interviews and self-administered questionnaires | Other | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with diffuse large B-cell lymphoma treated with CART-cells in the center during the inclusion period.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine RIOUFOL, Pharm. D | Contact | 04 78 86 43 70 | +33 | catherine.rioufol@chu-lyon.fr |
| Vérane SCHWIERTZ, Pharm. D | Contact | 04 78 86 43 59 | +33 | verane.schwiertz@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon -Groupement Hospitalier Sud Service pharmaceutique, Unité de Pharmacie Clinique Oncologique | Recruiting | Pierre-Bénite | 69495 | France |
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