Skip to main content
OpenTrials
Completed

NCT Number: NCT06392763

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diffuse Large B-cell Lymphoma Acute Lymphoblastic Leukemia (ALL) Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

Rueil-Malmaison, 92563, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of medicine, surgery, obstetrics and odontology (MCO) stays per patient

    Time frame: Up to 36 months

  2. Number of outpatient visit (ACE) stays per patient

    Time frame: Up to 36 months

  3. Number of emergency room visits not followed by hospitalisation per patient

    Time frame: Up to 36 months

  4. Number of aftercare and rehabilitation (SSR) stays per patient

    Time frame: Up to 36 months

  5. Number of homecare (HAD) stays per patient

    Time frame: Up to 36 months

  6. Number of consultations per type of healthcare professional

    Time frame: Up to 36 months

  7. Number of consultations per patient (all consultations combined)

    Time frame: Up to 36 months

  8. Number of patients who died

    Time frame: Up to 36 months

  9. Cost of MCO hospitalisation

    Time frame: Up to 36 months

  10. Cost of CAR-T on the supplementary list

    Time frame: Up to 36 months

  11. Cost of medicines on the supplementary list (excluding CAR-T)

    Time frame: Up to 36 months

  12. Hospitalisation cost

    Time frame: Up to 36 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 30, 2024
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.