Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369389
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-12
Brief Title:
Real-life Management of Patients Eligible for CAR-T Cell Therapy
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
Official Title:
Evaluation of the Real-life Management of Patients Eligible for CAR-T Cell Therapy for Hematologic Malignancies at Toulouse University Hospital
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARAVAGE
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None