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This was a Retrospective cohort study based on the PMSI data source
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:
YESCARTA®DLBCL cohort:
KYMRIAH® ALL cohort:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult R/R DLBCL cohort: KYMRIAH | Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma [R/R DLBCL]) |
| |
| Adult R/R DLBCL cohort: 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KYMRIAH | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival: number of events | 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). | through study completion, approximately 2 years (January 2017 to December 2019) |
| Time to next treatment (TTNT) analysis: number of events | Time to next treatment indicator was defined as the time between CAR-T injection and the date of the hospitalization or palliative care. | through study completion, approximately 2 years (January 2017 to December 2019) |
| Time to next treatment (TTNT) or death analysis: number of events | 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. | through study completion, approximately 2 years (January 2017 to December 2019) |
| Follow-up time between the CAR-T injection and the last hospital stay observed | Follow-up is the time between the CAR-T injection (index date) and the last hospital stay observed. | through study completion, approximately 2 years (January 2017 to December 2019) |
| Overall cost for CAR-T hospitalization | 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 | through study completion, approximately 2 years (January 2017 to December 2019) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients ( ≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma [R/R DLBCL]), currently being treated in third line or more with
Pediatric and young adult patients (≤25 years of age) with B cell acute lymphoblastic leukemia ( refractory, in relapse post transplant or in second or later relapse, currently being treated in third line or higher with
• KYMRIAH
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | East Hanover | New Jersey | 07936-1080 | United States |
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| Label | URL |
|---|---|
| Results for CCTL019A0FR02 from the Novartis Clinical Trials Results Database | View source |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000626284 | tisagenlecleucel |
| C000629083 | axicabtagene ciloleucel |
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|
| YESCARTA | Other | Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma [R/R DLBCL]) |
|
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |