Clinical trial NCT06271369: Real-World HRU and Costs in DLBCL Pts With Tisa-cel and Axi-cel, a Medicare Study.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diffuse Large B-cell Lymphoma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-02-21
Enrollment: 613
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with IP admission
timeFrame: Up to approximately 6 years
measure: Number of IP admissions
timeFrame: Up to approximately 6 years
measure: IP days
timeFrame: Up to approximately 6 years
measure: Number of ICU stays
timeFrame: Up to approximately 6 years
measure: ICU days
timeFrame: Up to approximately 6 years
measure: Number of patients with OP visit
timeFrame: Up to approximately 6 years
measure: Number of OP visits
timeFrame: Up to approximately 6 years
measure: Number of patients with ER visit
timeFrame: Up to approximately 6 years
measure: Number of ER visits
timeFrame: Up to approximately 6 years
measure: Healthcare reimbursement costs
timeFrame: Up to approximately 6 years
measure: Overall survival (OS)
timeFrame: Up to approximately 6 years
measure: Time to next treatment (TTNT) or death
timeFrame: Up to approximately 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: