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

NCT05532761 | Unknown

• 1 other identifier: 69HCL22_0430
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Diffuse large B-cell lymphoma (DLBCL); CAR-T cells; Quality of life; Real-life

Outcome Measures

Primary Outcomes (1)

• Change of mean score of FACT-Lym (Functional Assessment of Cancer Therapy - Lymphoma) quality of life

  Baseline (day before chemotherapy of lymphodepletion), Month1, 3, 6, 9, 12 and 18 after injection of CAR-T cells

Study Arms (1)

diffuse lare B cells lymphoma

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

Other: self-administered questionnaires

Interventions

self-administered questionnaires 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.

diffuse lare B cells lymphoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diffuse large cell B-cell lymphoma followed in the hematology department of Pr GUESQUIERES (Pierre-Bénite, France) whose treatment with CAR-T cells is planned will be offered participation in the QUALITOP CAR-T study. The number of patients with DLBCL benefiting annually from treatment with CAR-T cells in hematologic department is around 55. The number of subjects to be included, estimated at 30 patients over one year, is therefore compatible with the recruitment

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service pharmaceutique, Hospices Civils de Lyon - Groupement Hospitalier Sud

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Catherine RIOUFOL, Pharm D

CONTACT

(0)478864368; catherine.rioufol@chu-lyon.fr

Magali MAIRE, Ph D

CONTACT

(0)478864334; magali.maire@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 8, 2022
• Study Start: September 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)