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

Diffuse Large B-cell Lymphoma (DLBCL) Clinical Trial

— QUALITOP CAR-T  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05532761
• Other study ID #: 69HCL22_0430
• Status: Not yet recruiting
• Start date: September 2022
• Est. completion date: March 2025

Study information

• Verified date: September 2022
• Source: Hospices Civils de Lyon
• Contact: Catherine RIOUFOL, Pharm D
• Phone: (0)478864368
• Email: catherine.rioufol[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma (DLBCL)
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Service pharmaceutique, Hospices Civils de Lyon - Groupement Hospitalier Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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