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

NCT ID: NCT04914091

Last Updated: 2026-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-31

Study Completion Date

2033-01-31

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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with diffuse large B-cell lymphoma treated with CART-cells

Semi-structured interviews and self-administered questionnaires

Intervention Type 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.

Interventions

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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 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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospices Civils de Lyon -Groupement Hospitalier Sud Service pharmaceutique, Unité de Pharmacie Clinique Oncologique

Pierre-Bénite, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Catherine RIOUFOL, Pharm. D

Role: CONTACT

04 78 86 43 70 ext. +33

Vérane SCHWIERTZ, Pharm. D

Role: CONTACT

04 78 86 43 59 ext. +33

Facility Contacts

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Catherine RIOUFOL, Pharm. D

Role: primary

04 78 86 43 70 ext. +33

Other Identifiers

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69HCL20_1182

Identifier Type: -

Identifier Source: org_study_id

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