CAR T Cells Real World Evidence Study Based on the French Hospital Claims Data Source (PMSI)
NCT ID: NCT05349201
Last Updated: 2022-07-01
Study Results
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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COMPLETED
273 participants
OBSERVATIONAL
2020-12-09
2021-05-28
Brief Summary
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Detailed Description
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The patients were identified based on the CAR-T administration hospital stay, between 2017 and 2019. Based on the exhaustivity of the database, all patients treated with CAR-T (since 2018) were identified.
The study design included multiple periods of analysis based on the CAR-T process. Three main periods were defined: the historical period, the CAR-T period, and the post CAR-T period. The CAR-T period was divided in 2 sub-periods: pre CAR-T (including the apheresis procedure and 15 days before this procedure) and per CAR-T (including the lymphodepletion and CAR-T cell injection hospital stay until the end at the discharge date related to CAR-T cell injection hospital stay). The follow-up period started at the end of CAR-T hospital stay.
CAR-T populations:
KYMRIAH® DLBCL cohort:
* Adult patients (≥18 years of age) with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
* Patient with a CAR-T administration hospital stay of Kymriah between 2017 and 2019
YESCARTA®DLBCL cohort:
* Adult patients (≥18 years of age) with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy:
* Patient with a CAR-T administration hospital stay of Yescarta between 2017 and 2019
KYMRIAH® ALL cohort:
* Pediatric and young adult patients (≤ 25 years of age) with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse:
* Patient with a CAR-T administration hospital stay of Kymriah between 2017 and 2019
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Adult R/R DLBCL cohort: KYMRIAH
Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\])
KYMRIAH
Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\]) or Pediatric and young adult patients (≤25 years of age) with B cell acute lymphoblastic leukemia (ALL) refractory, in relapse post transplant or in second or later relapse
Adult R/R DLBCL cohort: YESCARTA
Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\])
YESCARTA
Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\])
ALL pediatric and young adult cohort: KYMRIAH
Pediatric and young adult patients (≤25 years of age) with B cell acute lymphoblastic leukemia (ALL) ( refractory, in relapse post transplant or in second or later relapse
KYMRIAH
Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\]) or Pediatric and young adult patients (≤25 years of age) with B cell acute lymphoblastic leukemia (ALL) refractory, in relapse post transplant or in second or later relapse
Interventions
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KYMRIAH
Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\]) or Pediatric and young adult patients (≤25 years of age) with B cell acute lymphoblastic leukemia (ALL) refractory, in relapse post transplant or in second or later relapse
YESCARTA
Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\])
Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed with ALL or DLBCL when administering CAR-T cells and
* up to 25 years for patients with ALL
18 Years
30 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
East Hanover, New Jersey, United States
Countries
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Related Links
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Results for CCTL019A0FR02 from the Novartis Clinical Trials Results Database
Other Identifiers
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CCTL019A0FR02
Identifier Type: -
Identifier Source: org_study_id
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