Real-World HRU and Costs in DLBCL Pts With Tisa-cel and Axi-cel, a Medicare Study.

Diffuse Large B-cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06271369
• Other study ID #: CCTL019CUS13
• Status: Completed
• Start date: August 11, 2022
• Est. completion date: February 15, 2023

Study information

• Verified date: February 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 613
• Est. completion date: February 15, 2023
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Locations

Country	Name	City	State
United States	Novartis	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with IP admission		Up to approximately 6 years
Primary	Number of IP admissions		Up to approximately 6 years
Primary	IP days	Described as the cumulative number of days during IP stays including ICU.	Up to approximately 6 years
Primary	Number of ICU stays	Described as the cumulative number of days during ICU stays.	Up to approximately 6 years
Primary	ICU days		Up to approximately 6 years
Primary	Number of patients with OP visit	OP services include office visits, skilled-nursing facility, home care, durable medical equipment, and other services that are not included in IP stays or ER visits.	Up to approximately 6 years
Primary	Number of OP visits		Up to approximately 6 years
Primary	Number of patients with ER visit		Up to approximately 6 years
Primary	Number of ER visits		Up to approximately 6 years
Primary	Healthcare reimbursement costs	Healthcare reimbursement costs were defined as the amount paid by Medicare to the provider for medical services.	Up to approximately 6 years
Primary	Overall survival (OS)	OS was defined as the time from administration of CAR-T therapy to death due to any cause.	Up to approximately 6 years
Primary	Time to next treatment (TTNT) or death	TTNT was defined as the time from administration of CAR-T therapy to the initiation of the next line of treatment or death due to any cause.	Up to approximately 6 years