Care Pathway and Associated Costs of Patients Treated With CAR T-cells Based on SNDS Data

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06392763

Enrollment

602

Registered

2024-04-30

Start date

2021-08-03

Completion date

2023-04-28

Last updated

2024-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia (ALL), Diffuse Large B-cell Lymphoma

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Number of medicine, surgery, obstetrics and odontology (MCO) stays per patient	Up to 36 months
Number of outpatient visit (ACE) stays per patient	Up to 36 months
Number of emergency room visits not followed by hospitalisation per patient	Up to 36 months
Number of aftercare and rehabilitation (SSR) stays per patient	Up to 36 months
Number of homecare (HAD) stays per patient	Up to 36 months
Number of consultations per type of healthcare professional	Up to 36 months
Number of consultations per patient (all consultations combined)	Up to 36 months
Number of patients who died	Up to 36 months
Cost of MCO hospitalisation	Up to 36 months
Cost of CAR-T on the supplementary list	Up to 36 months
Cost of medicines on the supplementary list (excluding CAR-T)	Up to 36 months
Hospitalisation cost	Up to 36 months

Countries

France

Outcome results