Multidimensional Assessment of Quality of Life, Social and Professional Life and Care Utilization in Patients With Diffuse Large Cell B-cell Lymphoma Treated With CAR-T Cells

NCT ID: NCT05532761

Last Updated: 2022-09-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2025-03-31

Brief Summary

Immunotherapy became in recent years a major innovation in the care of cancer patients, with unprecedented improvement in complete response and survival, particularly in hematological cancers. Since 2018, patients with relapsed or refractory lymphoma can benefit from immunotherapy based on CAR-T cells (Chimeric Antigenic Receptor - T cells), drugs derived from gene therapy and products from the patient's own T cells. The efficacy of these drugs, their development in more and more indications and in continuous earlier lines of treatment, their unprecedented adverse effects and their very high cost justify the search for predictive factors of efficacy and tolerance in order to optimize their use and benefit the greatest number of eligible patients. A better understanding of quality of life and its determinants in patients who received CAR-T cells could play a major role in predicting efficacy and tolerance. Quality of life data have indeed been deemed insufficient in phase 1-2 trials which have demonstrated the benefit of CAR-T cells in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in 3rd line of treatment or more and led to obtaining their marketing authorization. It is therefore necessary to assess the quality of life of patients treated in routine care with CAR-T cells. The European Qualitop project aims, from self-questionnaires, to explore the quality of life during the 2 years following the initiation of immunotherapy with a multidimensional approach integrating genetic factors, lifestyle habits and psychosocial determinants of patients. In this context, the Qualitop CAR-T study is a prospective non-comparative real-life study aimed at describing the multidimensional quality of life, its psychosocial determinants and drug consumption in patients with relapsed or refractory DLBCL treated with CAR -T cells.

Conditions

Diffuse Large B-cell Lymphoma (DLBCL); CAR-T Cells Treatment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

diffuse lare B cells lymphoma

Diffuse large B cells lymphoma patients eligibles for CAR-T cells therapy

self-administered questionnaires

Intervention Type: OTHER

In order to describe the experience of CAR-T cell therapy of DLBCL patients, a pharmaceutical follow-up is carried out the day before the injection (baseline) and at 1, 3, 6, 9, 12 and 18 months. These follow-ups consist of interviews with the patient and the delivery of self-administered questionnaires. The interviews will investigate drug consumption, the use of self-medication and complementary alternative therapies and the adverse effects of interest. The self-questionnaires will focus on exploring multidimensional quality of life, social and professional life, anxiety-depression or uncertainty tolerance through internationally validated questionnaires.

No supplementary visits will be needed : interviews with the research team will occur at the end of hematologic consultations.

Interventions

self-administered questionnaires

In order to describe the experience of CAR-T cell therapy of DLBCL patients, a pharmaceutical follow-up is carried out the day before the injection (baseline) and at 1, 3, 6, 9, 12 and 18 months. These follow-ups consist of interviews with the patient and the delivery of self-administered questionnaires. The interviews will investigate drug consumption, the use of self-medication and complementary alternative therapies and the adverse effects of interest. The self-questionnaires will focus on exploring multidimensional quality of life, social and professional life, anxiety-depression or uncertainty tolerance through internationally validated questionnaires.

No supplementary visits will be needed : interviews with the research team will occur at the end of hematologic consultations.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• over 18 years old
• eligible for treatment with CAR-Tcells (outside a clinical trial) in an indication of diffuse large B-cell lymphoma for which treatment with CAR-Tcells is scheduled
• follow-up in the Hematology department of the Hospices Civils de Lyon (Pr. Hervé Ghesquières)
• having given their non-objection to participate in the study.

Exclusion Criteria

• Adults subject to a measure of legal protection (curatorship, guardianship)
• Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care and persons admitted to a health or social establishment
• People with a major psychiatric disorder likely to hinder the conduct of the study, in the opinion of the investigator
• Not fluent in French-
• simultaneous participation in another research involving the human person, except if it is a study falling within category 3 of the Jardé Law which does not call into question the follow-up of patients in the present study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service pharmaceutique, Hospices Civils de Lyon - Groupement Hospitalier Sud

Pierre-Bénite, , France

Countries

France

Central Contacts

Catherine RIOUFOL, Pharm D

Role: CONTACT

catherine.rioufol@chu-lyon.fr

(0)478864368 ext. +33

Magali MAIRE, Ph D

Role: CONTACT

magali.maire@chu-lyon.fr

(0)478864334 ext. +33

Facility Contacts

Magali MAIRE, Ph D

Role: primary

magali.maire@chu-lyon.fr

(0)478864334 ext. +33

Other Identifiers

69HCL22_0430

Identifier Type: -

Identifier Source: org_study_id