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Completed

NCT Number: NCT05918809

Real-world Resource Use and Costs of CAR-T Therapies in Diffuse Large B-cell Lymphoma (DLBCL): Inpatient and Outpatient Settings

A retrospective, non-interventional cohort study was used to address the study objectives. This study aimed to provide a better understanding of real-world healthcare resource utilization (HRU) and healthcare reimbursement costs associated with chimeric antigen receptor modified T cell (CAR-T) therapy among patients with DLBCL.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

CAR-T cohort:

  • Patients had at least one International Classification of Diseases, Tenth Revision (ICD-10) diagnosis code for DLBCL.
  • Patients received CAR-T therapy following DLBCL diagnosis. The administration date of CAR-T therapy was defined as the index date. Patients who received both CAR-T therapy and allo-HSCT were classified based on the first treatment that the patient received.
  • Patients were at least 18 years of age as of the index date.
  • Patients had at least three months of continuous eligibility in the Medicare Part A and Part B data before the index date. Since 2020 Part D data is not available in the current data cut; eligibility requirement in the Part D data was not required.
  • Patients were further classified into CAR-T IP and CAR-T OP cohorts depending on where the administration occurred.

Allo-HSCT cohort:

  • Patients had at least one ICD-10 diagnosis code for DLBCL.
  • Patients received allo-HSCT following DLBCL diagnosis. The date of allo-HSCT procedure was defined as the index date. Patients who received both CAR-T therapy and allo-HSCT were classified based on the first treatment the patient received.
  • Patients were at least 18 years of age as of the index date.
  • Patients had at least three months of continuous eligibility in the Medicare Part A and Part B data before the index date. Since 2020 Part D data is not available in the current data cut; eligibility requirement in the Part D data was not required.

Exclusion criteria

  • Patients had a medical claim associated with a clinical trial (ICD-9 CM code V70.7; ICD-10 CM code Z00.6) during one month before and after the index date.

Treatment and study plan

Primary outcomes

  1. Number of hospital admissions in the CAR-T IP and CAR-T OP cohorts

    Time frame: Up to approximately 10 months

  2. Number of inpatient (IP) days in the CAR-T IP and CAR-T OP cohorts

    Time frame: Up to approximately 10 months

  3. Number of intensive care unit (ICU) stays in the CAR-T IP and CAR-T OP cohorts

    Time frame: Up to approximately 10 months

  4. Number of ICU days in the CAR-T IP and CAR-T OP cohorts

    Time frame: Up to approximately 10 months

  5. Number of emergency room (ER) visits in the CAR-T IP and CAR-T OP cohorts

    Time frame: Up to approximately 10 months

  6. Number of outpatient (OP) visits in the CAR-T IP and CAR-T OP cohorts

    Time frame: Up to approximately 10 months

  7. Percentage of patients in the CAR-T IP and CAR-T OP cohorts with any IP admission

    Time frame: Up to approximately 10 months

  8. Percentage of patients in the CAR-T IP and CAR-T OP cohorts with ER visits

    Time frame: Up to approximately 10 months

  9. Percentage of patients in the CAR-T IP and CAR-T OP cohorts with OP services

    Time frame: Up to approximately 10 months

  10. Total pre-infusion healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts

    Time frame: Up to approximately 10 months

  11. Total CAR-T infusion-related healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts

    Time frame: Up to approximately 10 months

  12. Total post-infusion healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts

    Time frame: Up to approximately 10 months

Secondary outcomes

  1. Cumulative percentage of patients admitted in the hospital during the first month after CAR-T OP infusion

    Time frame: Up to approximately 10 months

  2. Percentage of patients hospitalized each day during the first month after CAR-T infusion among the CAR-T IP and OP cohorts

    Time frame: Up to approximately 10 months

  3. Main cause of IP admission/re-admission among the CAR-T IP and OP cohorts, up to three months following infusion

    Time frame: Up to approximately 10 months

  4. Percentage of patients with AEs

    Time frame: Up to approximately 10 months

  5. Healthcare reimbursement costs per AE event

    Time frame: Up to approximately 10 months

  6. Number of IP admissions in the overall CAR-T and allo-HSCT cohorts

    Time frame: Up to approximately 10 months

  7. Number of IP days in the overall CAR-T and allo-HSCT cohorts

    Time frame: Up to approximately 10 months

  8. Number of OP visits in the overall CAR-T and allo-HSCT cohorts

    Time frame: Up to approximately 10 months

  9. Number of ER visits in the overall CAR-T and allo-HSCT cohorts

    Time frame: Up to approximately 10 months

  10. Total healthcare reimbursement costs in the overall CAR-T and allo-HSCT cohorts

    Time frame: Up to approximately 10 months

  11. Main cause of IP admission/re-admission among the CAR-T IP and OP cohorts

    Time frame: Up to approximately 10 months

  12. Number of intensive care unit (ICU) stays in the overall CAR-T and allo-HSCT cohorts

    Time frame: Up to approximately 10 months

  13. Number of ICU days in the overall CAR-T and allo-HSCT cohorts

    Time frame: Up to approximately 10 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 26, 2023
Registry last updated
Jun 26, 2023

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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