Clinical trial NCT06392763: Care Pathway and Associated Costs of Patients Treated With CAR T-cells Based on SNDS Data
Official title: Care Pathway and Associated Costs of Patients Treated With CAR T-cells Based on SNDS Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diffuse Large B-cell Lymphoma
Acute Lymphoblastic Leukemia (ALL)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-04-30
Enrollment: 602
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study

Brief summary: This retrospective cohort study, based on the French medico-administrative database (SNDS), evaluated the care pathway, the effectiveness of management and the costs associated with patients treated with chimeric antigen receptor (CAR) T cells (CART-cells) (KYMRIAH or YESCARTA): paediatric and young adult patients (up to and including 25 years of age) with acute lymphoblastic leukaemia (ALL); and adult patients (18 years of age or older) with DLBCL.


Eligibility criteria: Inclusion criteria:

DLBCL population:

* Patients with hospitalisation for CAR T-cell administration from 2017 to 2020 AND
* Diagnosed with DLBCL (International Classification of Diseases \[ICD-10 C833\]) when receiving CAR-T AND
* Being 18 years of age or older.

ALL population:

* Patients with hospitalisation for CAR T-cell administration from 2017 to 2020 AND
* Diagnosed with ALL (ICD-10 C910) when receiving CAR-T AND
* Being 25 years of age or younger.

Exclusion criteria:

DLBCL population:

• Patients hospitalised with a diagnosis other than DLBCL during the historical period or during the index stay.

ALL population:

• Patients hospitalised with a diagnosis other than ALL during the historical period or during the index stay.

Primary outcomes:
measure: Number of medicine, surgery, obstetrics and odontology (MCO) stays per patient
timeFrame: Up to 36 months
measure: Number of outpatient visit (ACE) stays per patient
timeFrame: Up to 36 months
measure: Number of emergency room visits not followed by hospitalisation per patient
timeFrame: Up to 36 months
measure: Number of aftercare and rehabilitation (SSR) stays per patient
timeFrame: Up to 36 months
measure: Number of homecare (HAD) stays per patient
timeFrame: Up to 36 months
measure: Number of consultations per type of healthcare professional
timeFrame: Up to 36 months
measure: Number of consultations per patient (all consultations combined)
timeFrame: Up to 36 months
measure: Number of patients who died
timeFrame: Up to 36 months
measure: Cost of MCO hospitalisation
timeFrame: Up to 36 months
measure: Cost of CAR-T on the supplementary list
timeFrame: Up to 36 months
measure: Cost of medicines on the supplementary list (excluding CAR-T)
timeFrame: Up to 36 months
measure: Hospitalisation cost
timeFrame: Up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rueil-Malmaison
country: France
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: