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

NCT06392763 | Completed

• 1 other identifier: CCTL019A0FR03
• Study Type: observational
• Target: 602
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (4)

KYMRIAH DLBCL

YESCARTA DLBCL

CAR-T DLBCL

KYMRIAH ALL

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

Rueil-Malmaison, 92563, France

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: April 30, 2024
• Study Start: August 3, 2021
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

FR (1)