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

• Conditions: Patients With Diffuse Large B-cell Lymphoma Treated With CART-cells
• Interventions: Other: Semi-structured interviews and self-administered questionnaires

• Registration Number: NCT04914091
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-03-31
• Study First Submitted: 2021-05-31
• Study First Submitted QC: 2021-05-31
• Study First Posted: 2021-06-04
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-02
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

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Exclusion Criteria

• In an institution
• Under legal protection

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with diffuse large B-cell lymphoma treated with CART-cells	Semi-structured interviews and self-administered questionnaires	-

Primary Outcome Measures

Name	Time	Method
Change of Mean quality of life score using the EORTC-QLQ C30 questionnaire	Inclusion (the day before lymphodepletion chemotherapy), Month 3 and Month 6 after the administration of CART-T cells	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).

Trial Locations

Locations (1)

Hospices Civils de Lyon -Groupement Hospitalier Sud Service pharmaceutique, Unité de Pharmacie Clinique Oncologique; 🇫🇷 Pierre-Bénite, France