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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Patients With Diffuse Large B-cell Lymphoma Treated With CART-cells
• Intervention / Treatment: Other: Semi-structured interviews and self-administered questionnaires

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Catherine RIOUFOL, Pharm. D; Phone Number: +33 04 78 86 43 70; Email: catherine.rioufol@chu-lyon.fr
• Study Contact Backup: Name: Vérane SCHWIERTZ, Pharm. D; Phone Number: +33 04 78 86 43 59; Email: verane.schwiertz@chu-lyon.fr

Study Locations

• France
  • Pierre-Bénite, France, 69495
    • Recruiting
    • Hospices Civils de Lyon -Groupement Hospitalier Sud Service pharmaceutique, Unité de Pharmacie Clinique Oncologique
    • Contact: Catherine RIOUFOL, Pharm. D; Phone Number: +33 04 78 86 43 70; Email: catherine.rioufol@chu-lyon.fr
    • Principal Investigator: Catherine RIOUFOL, Pharm. D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with diffuse large B-cell lymphoma treated with CART-cells in the center during the inclusion period.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2021
• Primary Completion (Estimated): January 31, 2033
• Study Completion (Estimated): January 31, 2033

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: May 31, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Quality of life; drug use; CAR-T cells
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: 69HCL20_1182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No