NCT05366257

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 healthcare reimbursement costs associated with CAR-T therapy among patients with r/r Diffuse Large B-cell Lymphoma (DLBCL).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160,602

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 17, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
Last Updated

July 5, 2022

Status Verified

June 1, 2022

Enrollment Period

9 months

First QC Date

May 4, 2022

Last Update Submit

June 29, 2022

Conditions

Diffuse Large B-cell Lymphoma (DLBCL)

Keywords

CAR-T,DLBCL,Inpatient,Outpatient

Outcome Measures

Primary Outcomes (11)

  • 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)

  • 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)

Secondary Outcomes (14)

  • 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)

  • +9 more secondary outcomes

Study Arms (3)

CAR-T: Inpatient (IP) Cohort

Patients received CAR-T infusion in IP setting

Other: CAR-T

CAR-T: Outpatient (OP) Cohort

Patients received CAR-T infusion in OP setting

Other: CAR-T

Allo-HSCT cohort

Patients received allogeneic hematopoietic stem cell transplant

Other: Allo-HSCT cohort

Interventions

CAR-TOTHER

infusion of CAR-T therapy among patients with r/r DLBCL

CAR-T: Inpatient (IP) CohortCAR-T: Outpatient (OP) Cohort
Allo-HSCT cohortOTHER

Patients received allogeneic hematopoietic stem cell transplant

Allo-HSCT cohort

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with DLBCL who received CAR-T therapy or allo-HSCT procedure between January 1, 2017 to September 31, 2019

You may qualify if:

  • 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

East Hanover, New Jersey, 07936-1080, United States

Location

Related Links

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2022

First Posted

May 9, 2022

Study Start

August 17, 2020

Primary Completion

May 10, 2021

Study Completion

May 10, 2021

Last Updated

July 5, 2022

Record last verified: 2022-06

Locations

US(1)