NCT07103486

A Study to Evaluate the Therapeutic Benefit of Tisagenlecleucel Compared to Existing Standard of Care in German Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Retrospective Chart Review for German Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) After Two or More Lines of Systemic Therapy With Subsequent Historical Comparison Against Tisagenlecleucel Based on JULIET Trial (CTL019C2201)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 264 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to evaluate the therapeutic benefit of tisagenlecleucel compared to the existing standard of care in adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). For tisagenlecleucel patients, patient-level data from the JULIET study (CTL019C2201) was used. Data for patients treated with the appropriate comparator therapy (ACT) in German routine care was collected via chart review by 8 medical centers in Germany. The medical charts provided data on adult patients at the time of the qualifying treatments in the time period from approximately 2010 to 2017 with the longest possible follow-up phases (up to 5 years, but only until December 31, 2020).

Conditions

• Diffuse Large B-Cell Lymphoma

Timeline

• Start date: 2021-04-01
• Primary completion: 2023-01-31
• Completion: 2023-01-31
• First posted: 2025-08-05
• Last updated: 2025-08-05

Locations

1 site across 1 country: United States