Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06271369
Status:
COMPLETED
Last Update Posted:
2024-02-21
First Post:
2024-02-14
Brief Title:
Real-World HRU and Costs in DLBCL Pts With Tisa-cel and Axi-cel a Medicare Study
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Real-world Study Comparing Tisagenlecleucel Tisa-cel With Axicabtagene Ciloleucel Axi-cel on Healthcare Resource Use HRU Costs and Overall Survival OS in Diffuse Large B-cell Lymphoma DLBCL A Retrospective Study of Medicare Population
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was a retrospective non-interventional cohort study design using the Centers for Medicare and Medicaid Services CMS 100 Medicare data 2015Q1-2020Q4
Eligible adult patients with rr DLBCL who were treated with CAR-T therapy were identified from the CMS 100 Medicare data Patients who received chimeric antigen receptor modified T cell CAR-T therapy were further classified into tisa-cel and axi-cel cohorts based on the type of CAR-T treatment received The index date was defined as the date of tisa-cel or axi-cel therapy administration Baseline period was defined as three months prior to the index date Study period was defined from the index date to the end of health plan coverage based on insurance enrollment file or death whichever occurred earlier
Eligible adult patients with rr DLBCL who were treated with CAR-T therapy were identified from the CMS 100 Medicare data Patients who received chimeric antigen receptor modified T cell CAR-T therapy were further classified into tisa-cel and axi-cel cohorts based on the type of CAR-T treatment received The index date was defined as the date of tisa-cel or axi-cel therapy administration Baseline period was defined as three months prior to the index date Study period was defined from the index date to the end of health plan coverage based on insurance enrollment file or death whichever occurred earlier
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None