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

NCT ID: NCT06271369

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 613 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-11
• Study Completion Date: 2023-02-15

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.

Conditions

Diffuse Large B-cell Lymphoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Tisa-cel cohort

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.

No interventions assigned to this group

Axi-cel cohort

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis

East Hanover, New Jersey, United States

Countries

United States

Other Identifiers

CCTL019CUS13

Identifier Type: -

Identifier Source: org_study_id