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

Evaluation of the Real-life Management of Patients Eligible for CAR-T Cell Therapy for Hematologic Malignancies at Toulouse University Hospital

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.

Study Overview

• Status: Recruiting
• Conditions: Hemopathy
• Intervention / Treatment: Other: Patients eligible for CAR-T treatment

Detailed Description

Ambispective observational cohort: This observational study is monocentric. For each patient, data will be collected during 5 years.

• Study Type: Observational
• Enrollment (Estimated): 550

Contacts and Locations

• Study Contact: Name: Sandra DE BARROS; Phone Number: 33 0561145982; Email: debarros.s@chu-toulouse.fr
• Study Contact Backup: Name: Pierre BORIES, MD; Phone Number: 33 0531156415; Email: bories.pierre@iuct-oncopole.fr

Study Locations

• France
  • CHU de Toulouse
    • Toulouse, CHU de Toulouse, France, 31059
      • Recruiting
      • CHU de Toulouse
      • Contact: Pierre BORIES, MD; Phone Number: 33 0531156415; Email: bories.pierre@iuct-oncopole.fr
      • Contact: Sandra DE BARROS; Phone Number: 0561145982; Email: debarros.s@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	progression-free survival from CAR-T cell injection to date of progression and overall survival from CAR-T cell injection to all-cause death progression-free survival from CAR-T cell injection to date of progression and overall survival from CAR-T cell injection to all-cause death	5 years
Evaluate the time taken to treat patients with CAR-T cells	number of days between the multidisciplinary consultation meeting and the injection of CAR-T cells	5 years

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: Janssen, LP; Ligue contre le cancer, France
• Investigators: Principal Investigator: Pierre BORIES, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2024
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): December 31, 2034

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: quality of life; CAR-T cells; care pathways; real life
• Other Study ID Numbers: RC31/23/0417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No