NCT06392763

Completed

Care Pathway and Associated Costs of Patients Treated With C...

Novartis Pharmaceuticals Source

Compare

Other study identifiers

Sponsor study identifier

CCTL019A0FR03

Study Type

observational

Actual enrollment (reported)

602

Locations

1 country

Sites

1

Timeline

Study Start

August 3, 2021

Actual (reported)

Primary Completion

April 28, 2023

Actual (reported)

Study Completion

April 28, 2023

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 602 participants
Study completion date: April 28, 2023
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 3, 2021
Actual (reported)
Primary Completion
April 28, 2023
Actual (reported)
Study Completion
April 28, 2023
Actual (reported)
First Submitted
April 26, 2024
Actual (reported)
First Posted
April 30, 2024
Actual (reported)

Last Updated: April 30, 2024
Status Verified: April 2024
Last Update Submitted: April 26, 2024

Conditions

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

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

Study Arms (4)

KYMRIAH DLBCL

YESCARTA DLBCL

CAR-T DLBCL

KYMRIAH ALL

Eligibility Criteria

Age1 Year+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

You may qualify if:

DLBCL population:

Sponsors & Collaborators

Novartis Pharmaceuticals
Industrylead

Study Sites (1)

Novartis

Rueil-Malmaison, 92563, France

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffusePrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidLeukemiaHematologic Diseases

Study Officials

Novartis Pharmaceuticals
Novartis Pharmaceuticals
STUDY DIRECTOR

Enrollment

602 participants (actual enrollment reported by the registry).

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

Actual (reported)

NCT05366569

Bio-CAR-T BS Study

Recruiting

NCT05541341

Effectiveness and Safety of Tisagenlecleucel Therapy in Brazilian Patients With B-lymphocyte Malignancies

Recruiting

NCT05168748

CD19- and CD22-directed CAR-T Cell Therapy in Patients With Acute Lymphoblastic Leukemia

Phase 1Withdrawn

NCT05366257

Real-world Resource Use and Costs of CAR-T Therapies in Diffuse Large B-cell Lymphoma (DLBCL)

Completed

NCT04456023

Study of Tisagenlecleucel in Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-cell Non-Hodgkin Lymphoma (DLBCL)

Phase 2Withdrawn

NCT07103486

A Study to Evaluate the Therapeutic Benefit of Tisagenlecleucel Compared to Existing Standard of Care in German Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Completed

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

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.

Contact the study team to confirm eligibility.

Primary Completion

April 28, 2023

Actual (reported)

Study Completion

April 28, 2023

Actual (reported)

Last Updated

April 30, 2024

Record last verified: 2024-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT06392763
Data provider: ClinicalTrials.gov
Source updated: 2024-04-30
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:47 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (12)

Study Arms (4)

KYMRIAH DLBCL

YESCARTA DLBCL

CAR-T DLBCL

KYMRIAH ALL

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations