An observational study in Diffuse Large B-Cell Lymphoma (DLBCL) and Acute Lymphoblastic Leukemia (ALL), sponsored by Novartis Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2022-07-01.
Sponsored by Novartis Pharmaceuticals · Observational
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:
2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 490 are open to participants now.
This study's enrollment of 273 is above the median of 120 across 300 observational studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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 \[R/R DLBCL\])
Other: YESCARTA
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
Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\])
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: through study completion, approximately 2 years (January 2017 to December 2019)
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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