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

Hemopathy Clinical Trial

— CARAVAGE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06369389
• Other study ID #: RC31/23-0417
• Status: Not yet recruiting
• Start date: April 30, 2024
• Est. completion date: December 31, 2034

Study information

• Verified date: April 2024
• Source: University Hospital, Toulouse
• Contact: Pierre BORIES, MD
• Phone: 0531156415
• Email: bories.pierre[@]iuct-oncopole.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 550
• Est. completion date: December 31, 2034
• Est. primary completion date: December 31, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemopathy

Intervention

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

Locations

Country	Name	City	State
France	CHU de Toulouse	Toulouse	CHU De Toulouse

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Janssen, LP, Ligue contre le cancer, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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