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Comparison of Clinical Outcomes Among Patients Treated With Tisagenlecleucel

Diffuse Large B-cell Lymphoma Clinical Trial

Official title:
Comparison of Clinical Outcomes Among Patients Treated With Tisagenlecleucel in the JULIET Trial Versus a Real-world, Retrospective Cohort of Patients Treated With Standard of Care for Relapsed or Refractory Diffuse Large B-cell Lymphoma

Clinical Trial Summary

This is a non-interventional, retrospective cohort study using the Flatiron Health Research Database (FHRD) and data from the single-arm phase II JULIET clinical trial (NCT02445248).

Clinical Trial Description

JULIET is a single-arm, open-label, multi-center phase II study of tisagenlecleucel involving adult patients with r/r DLBCL who were ineligible for or had disease progression after autologous hematopoietic stem-cell transplantation. Patients enrolled in JULIET will be referred to as the trial cohort in this study. Outcomes observed in the trial cohort will be compared against a cohort of patients receiving standard of care, defined as the real-world cohort in this study. The real-world cohort will be derived from the FHRD by applying relevant JULIET trial inclusion and exclusion criteria that are feasible to apply in the FHRD. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05541328
Study type Observational
Source Novartis
Contact
Status Completed
Phase
Start date February 3, 2020
Completion date February 5, 2021
View Details
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