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Completed

NCT Number: NCT06271369

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

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.

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Key information

Conditions

Diffuse Large B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of patients with IP admission

    Time frame: Up to approximately 6 years

  2. Number of IP admissions

    Time frame: Up to approximately 6 years

  3. IP days

    Time frame: Up to approximately 6 years

    Described as the cumulative number of days during IP stays including ICU.

  4. Number of ICU stays

    Time frame: Up to approximately 6 years

    Described as the cumulative number of days during ICU stays.

  5. ICU days

    Time frame: Up to approximately 6 years

  6. Number of patients with OP visit

    Time frame: Up to approximately 6 years

    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.

  7. Number of OP visits

    Time frame: Up to approximately 6 years

  8. Number of patients with ER visit

    Time frame: Up to approximately 6 years

  9. Number of ER visits

    Time frame: Up to approximately 6 years

  10. Healthcare reimbursement costs

    Time frame: Up to approximately 6 years

    Healthcare reimbursement costs were defined as the amount paid by Medicare to the provider for medical services.

  11. Overall survival (OS)

    Time frame: Up to approximately 6 years

    OS was defined as the time from administration of CAR-T therapy to death due to any cause.

  12. Time to next treatment (TTNT) or death

    Time frame: Up to approximately 6 years

    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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2024
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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