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

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Novartis

Status

Completed

Conditions

Diffuse Large B-cell Lymphoma

Study type

Observational

Funder types

Industry

Identifiers

NCT05918809
CCTL019CUS11

Details and patient eligibility

About

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.

Enrollment

1,031 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

1,031 participants in 4 patient groups

CAR-T IP
Description:
Chimeric antigen receptor modified T cells inpatient cohort
CAR-T OP
Description:
Chimeric antigen receptor modified T cells outpatient cohort
CAR-T Overall
Description:
Chimeric antigen receptor modified T cells overall cohort
allo-HSCT
Description:
Allogeneic hematopoietic stem cell transplant cohort

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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