Sponsor study identifier
observational
160,602
1 country
1
Study Start
August 17, 2020
Actual (reported)Primary Completion
May 10, 2021
Actual (reported)Study Completion
May 10, 2021
Actual (reported)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 CAR-T therapy among patients with r/r Diffuse Large B-cell Lymphoma (DLBCL).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 10, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 17, 2020
Actual (reported)May 10, 2021
Actual (reported)May 10, 2021
Actual (reported)May 4, 2022
Actual (reported)May 9, 2022
Actual (reported)Mean length of follow-up in CAR-T cohorts
Mean length of follow up was reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of patients with IP visit in CAR-T cohorts
Number of patients with IP visit were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of IP admissions in CAR-T cohorts
Number of IP admissions were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of IP days in CAR-T cohorts
Number of patients with IP visit were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Mean length of follow-up for CAR-T therapy vs. allo-HSCT cohort
throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of patients with IP visit in CAR-T vs allo-HSCT cohort
throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of IP admissions in CAR-T therapy vs. allo-HSCT cohort
throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of IP days in CAR-T therapy vs. allo-HSCT cohort
throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of ICU stays in CAR-T therapy vs. allo-HSCT cohort
throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Patients received CAR-T infusion in IP setting
Patients received CAR-T infusion in OP setting
Patients received allogeneic hematopoietic stem cell transplant
infusion of CAR-T therapy among patients with r/r DLBCL
Patients received allogeneic hematopoietic stem cell transplant
Adult patients with DLBCL who received CAR-T therapy or allo-HSCT procedure between January 1, 2017 to September 31, 2019
Novartis Investigative Site
East Hanover, New Jersey, 07936-1080, United States
Novartis Pharmaceuticals
Novartis Pharmaceuticals
160,602 participants (actual enrollment reported by the registry).
First Submitted
May 4, 2022
First Posted
May 9, 2022
Study Start
August 17, 2020
Actual (reported)Real-World HRU and Costs in DLBCL Pts With Tisa-cel and Axi-cel, a Medicare Study.
Number of ICU stays in CAR-T cohorts
Number of ICU stays were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of ICU days in CAR-T cohorts
Number of ICU days were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of patients with OP visit in CAR-T cohorts
Number of patients with OP visit were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of OP visits in CAR-T cohorts
Number of OP visits were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of patients with ER visit in CAR-T cohorts
Number of patients with ER visit were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of ER visits in CAR-T cohorts
Number of ER visits were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Total healthcare reimbursement costs in CAR-T cohorts
Total healthcare reimbursement costs, including medical service costs and pharmacy costs, inflated to 2020 US dollars (USD) were reported in CAR-T IP and CAR-T OP cohorts.
throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 10, 2021
Actual (reported)Study Completion
May 10, 2021
Actual (reported)Last Updated
July 5, 2022
Record last verified: 2022-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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