Clinical trial NCT06369389: Real-life Management of Patients Eligible for CAR-T Cell Therapy
Official title: Evaluation of the Real-life Management of Patients Eligible for CAR-T Cell Therapy for Hematologic Malignancies at Toulouse University Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hemopathy
Keywords: CAR-T cells
real life
care pathways
quality of life
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Ligue contre le cancer, France
name: Janssen, LP
First posted: 2024-04-17
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival of patients with hemopathy eligible for CAR-T cell therapy
timeFrame: 5 years
Secondary outcomes:
measure: 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
timeFrame: 5 years
measure: Evaluate the time taken to treat patients with CAR-T cells
timeFrame: 5 years
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de Toulouse
state: CHU de Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Pierre BORIES, MD
role: PRINCIPAL_INVESTIGATOR
References: