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

Diffuse Large B-cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06392763
• Other study ID #: CCTL019A0FR03
• Status: Completed
• Start date: August 3, 2021
• Est. completion date: April 28, 2023

Study information

• Verified date: April 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 602
• Est. completion date: April 28, 2023
• Est. primary completion date: April 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
France	Novartis	Rueil-Malmaison

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

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