Acute Lymphoblastic Leukemia (ALL), Diffuse Large B-Cell Lymphoma (DLBCL)
Conditions
Brief summary
This was a Retrospective cohort study based on the PMSI data source
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: * 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
Interventions
OTHERKYMRIAH
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
OTHERYESCARTA
Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\])
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* Patients treated with CAR-T cells from 2017 to 2019 and informed as such in the PMSI And * Patients diagnosed with ALL or DLBCL when administering CAR-T cells and * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed