NCT05541328

Comparison of Clinical Outcomes Among Patients Treated With Tisagenlecleucel

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 169 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
OTHER	Tisagenlecleucel	The trial cohort is defined as the cohort of patients enrolled in JULIET who were assigned to receive tisagenlecleucel infusion

Timeline

• Start date: 2020-02-03
• Primary completion: 2021-02-05
• Completion: 2021-02-05
• First posted: 2022-09-15
• Last updated: 2022-09-15

Locations

1 site across 1 country: United States