Идёт набор NCT04914091

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

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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Semi-structured interviews and self-administered questionnaires.
Кому может быть актуально: Состояния в реестре: Patients With Diffuse Large B-cell Lymphoma Treated With CART-cells. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Другое 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

Первичные конечные точки

Change of Mean quality of life score using the EORTC-QLQ C30 questionnaire [Срок оценки: Inclusion (the day before lymphodepletion chemotherapy), Month 3 and Month 6 after the administration of CART-T cells]

Критерии участия

Критерии включения

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.