Clinical trial · Observational
Real-World HRU and Costs in DLBCL Pts With Tisa-cel and Axi-cel, a Medicare Study.
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 r/r 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Tisa-cel cohort
- description
- Patients with at least one ICD-10 diagnosis for DLBCL who were at least 18 years old. Patients also had at least three months of continuous health plan enrollment before administration of CAR-T therapy and received tisa-cel following DLBCL diagnosis.
- label
- Axi-cel cohort
- description
- Patients with at least one ICD-10 diagnosis for DLBCL who were at least 18 years old. Patients also had at least three months of continuous health plan enrollment before administration of CAR-T therapy and received axi-cel following DLBCL diagnosis.
Primary outcomes (12)
- measure
- Number of patients with IP admission
- timeFrame
- Up to approximately 6 years
- measure
- Number of IP admissions
- timeFrame
- Up to approximately 6 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients had at least one International Classification of Diseases, 10th Revision (ICD-10) diagnosis code for DLBCL. * Patients received CAR-T therapy, including both tisa-cel and axi-cel, following DLBCL diagnosis. The administration date of CAR-T therapy was defined as the index date. * Patients were at least 18 years of age as of the index date. * Patients had at least three months of continuous health plan enrollment before the index date. Exclusion Criteria: * Patients who had a medical claim associated with a clinical trial within one month before and after the index date. * Patients who had zero cost on index date for CAR-T infusion.
References
Publications (0)
Data not yet available