CAR T Cells Real World Evidence Study Based on the French Hospital Claims Data Source (PMSI)
Study Details
Study Description
Brief Summary
This was a Retrospective cohort study based on the PMSI data source
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
A retrospective database analysis was performed using the French national hospital claims database (Medicalized Information System Program - PMSI, 2015-2019), which includes discharge summaries for all hospital admissions in France (~99% of French residents).
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:
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Adult patients (≥18 years of age) with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
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Patient with a CAR-T administration hospital stay of Kymriah between 2017 and 2019
YESCARTA®DLBCL cohort:
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Adult patients (≥18 years of age) with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy:
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Patient with a CAR-T administration hospital stay of Yescarta between 2017 and 2019
KYMRIAH® ALL cohort:
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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:
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Patient with a CAR-T administration hospital stay of Kymriah between 2017 and 2019
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Adult R/R DLBCL cohort: KYMRIAH Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma [R/R DLBCL]) |
Other: 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]) |
Other: 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 |
Other: 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
|
Outcome Measures
Primary Outcome Measures
- Overall survival: number of events [through study completion, approximately 2 years (January 2017 to December 2019)]
Overall survival indicator was defined as all cause death recorded at the hospital (MSO, HAD, SSR). Patients were censored at the date of last hospitalization observed (MSO/HAD/SSR/ACE).
- Time to next treatment (TTNT) analysis: number of events [through study completion, approximately 2 years (January 2017 to December 2019)]
Time to next treatment indicator was defined as the time between CAR-T injection and the date of the hospitalization or palliative care.
- Time to next treatment (TTNT) or death analysis: number of events [through study completion, approximately 2 years (January 2017 to December 2019)]
Time to next treatment or death indicator was defined as the first event occurring between TNTT or death presented during the hospitalization or palliative care.
- Follow-up time between the CAR-T injection and the last hospital stay observed [through study completion, approximately 2 years (January 2017 to December 2019)]
Follow-up is the time between the CAR-T injection (index date) and the last hospital stay observed.
- Overall cost for CAR-T hospitalization [through study completion, approximately 2 years (January 2017 to December 2019)]
The CAR-T hospitalization included Medical, Surgical, Obstetrics (MSO) hospitalization tariff and extra tariff linked to CAR-T treatment reimbursed by the health care insurance
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients treated with CAR-T cells from 2017 to 2019 and informed as such in the PMSI And
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Patients diagnosed with ALL or DLBCL when administering CAR-T cells and
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up to 25 years for patients with ALL
Exclusion Criteria:
- All patients treated outside the two types of indications presented in the inclusion criteria will be excluded
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | East Hanover | New Jersey | United States | 07936-1080 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CCTL019A0FR02