Status:
COMPLETED
Real-world Resource Use and Costs of CAR-T Therapies in Diffuse Large B-cell Lymphoma (DLBCL)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Diffuse Large B-cell Lymphoma (DLBCL)
Eligibility:
All Genders
18-85 years
Brief Summary
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 he...
Detailed Description
A retrospective, non-interventional cohort study was used to address the study objectives. This study aimed to provide a better understanding of real-world HRU and healthcare reimbursement costs assoc...
Eligibility Criteria
Inclusion
- 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 2019 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 2019 Part D data is not available in the current data cut, eligibility requirement in the Part D data was not required
Exclusion
- \- 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
Key Trial Info
Start Date :
August 17 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 10 2021
Estimated Enrollment :
160602 Patients enrolled
Trial Details
Trial ID
NCT05366257
Start Date
August 17 2020
End Date
May 10 2021
Last Update
July 5 2022
Active Locations (1)
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1
Novartis Investigative Site
East Hanover, New Jersey, United States, 07936-1080