Real-life Management of Patients Eligible for CAR-T Cell Therapy

NCT06369389 | Recruiting

• 1 other identifier: RC31/23/0417
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

Adoptive immunotherapy using CAR-T cells is now one of the Advanced Therapy Medicines routinely used for relapsed or refractory lymphoid hemopathies. In 2023, in France, 5 types of CAR-T cells have marketing authorization for 6 different indications. However, these marketing authorizations are based on clinical trials involving a limited number of selected patients. Real-life data are essential for assessing the post-authorization use of these innovative treatments. The French national DESCAR-T registry, promoted by LYSARC and in which Toulouse University Hospital plays an active role, is an international reference for this real-life evaluation. It does not, however, allow precise evaluation of patient-centered indicators and care pathways. With the increasing number of indications and candidate patients, Toulouse University Hospital, the only healthcare facility authorized in the Western Occitanie region to administer CAR-T cells, is faced with growing hospital needs and longer treatment times. In 2023, this has necessitated the implementation of new ambulatory and inter-facility care pathways in collaboration with the referral centers of the Onco-Occitanie Ouest regional cancer network. The selection of patients for CAR-T cell treatment is based on objective clinical criteria linked to the pathology (histology, morphological localization, size and kinetics of the tumor mass) and the patient (physiological age, performance index, comorbidities, patient choice). Because of their innovative nature, in a difficult psychological and physical context for the patient (refractory disease), CAR-T cell care pathways also need to be evaluated in terms of their "quality of life" dimension. The impact of non-biological determinants (also described as social and territorial inequalities in health) such as place of residence and distance from healthcare provision, marital, economic and social status, has never been explored on the accessibility and progress of the CAR-T cell treatment pathway. The creation of a registry of patients eligible for CAR-T cells at Toulouse University Hospital will enable these lines of research to be explored on the scale of a region with a population of 3 million.

Conditions

Hemopathy

Keywords

CAR-T cells; real life; care pathways; quality of life

Outcome Measures

Primary Outcomes (1)

• Overall survival of patients with hemopathy eligible for CAR-T cell therapy

  Overall survival from CAR-T cell injection to all-cause death

  5 years

Secondary Outcomes (2)

• Compare progression-free survival and overall survival of patients according to care pathway and type of hemopathy, and investigate clinical and socioeconomic factors associated with better survival

  5 years

• Evaluate the time taken to treat patients with CAR-T cells

  5 years

Study Arms (1)

Patients eligible for CAR-T treatment

Patients eligible for CAR-T treatment for their hemopathy at TOULOUSE University Hospital under early access or marketing authorization or as part of a clinical trial between 01/01/2019 and 31/12/2028

Other: Patients eligible for CAR-T treatment

Interventions

Patients eligible for CAR-T treatment OTHER

Patients eligible for CAR-T treatment for their hemopathy at TOULOUSE University Hospital under early access or marketing authorization or as part of a clinical trial between 01/01/2019 and 31/12/2028

Patients eligible for CAR-T treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient major eligible for CAR-T treatment for hemopathy at TOULOUSE University Hospital under early access or marketing authorization or as part of a clinical trial between 01/01/2019 and 31/12/2028

You may qualify if:

• Patient eligible for CAR-T treatment for hemopathy at TOULOUSE University Hospital under early access or marketing authorization or as part of a clinical trial between 01/01/2019 and 31/12/2028
• Patient able to understand the purpose and constraints of the research project
• Patient has read the study information leaflet and does not object to the research.

You may not qualify if:

• Patient under guardianship, curatorship or safeguard of justice
• Patient objects to the collection of data concerning him/her

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Ligue contre le cancer, France: collaborator
• Janssen, LP: collaborator

Study Sites (1)

CHU de Toulouse

Toulouse, CHU de Toulouse, 31059, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

Study Officials

• Pierre BORIES, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre BORIES, MD

CONTACT

0531156415; bories.pierre@iuct-oncopole.fr

Sandra DE BARROS

CONTACT

0561145982; debarros.s@chu-toulouse.fr

Study Design

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

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 17, 2024
• Study Start: April 30, 2024
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): December 31, 2034
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)