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

NCT ID: NCT06392763

Last Updated: 2024-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

602 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-03

Study Completion Date

2023-04-28

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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KYMRIAH DLBCL

No interventions assigned to this group

YESCARTA DLBCL

No interventions assigned to this group

CAR-T DLBCL

No interventions assigned to this group

KYMRIAH ALL

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis

Rueil-Malmaison, , France

Site Status

Countries

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France

Other Identifiers

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CCTL019A0FR03

Identifier Type: -

Identifier Source: org_study_id