NCT07039383

A Real-world Study of the Effectiveness of Tisagenlecleucel in Acute Lymphoblastic Leukemia Patients

Kymriah Real-world Effectiveness in ALL (KareALL): a Retrospective Chart Review Study of Tisagenlecleucel-treated ALL Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 79 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This was a retrospective, cross-sectional, center-based chart review study that collected real-world data for relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL) patients receiving tisagenlecleucel (tisa-cel). Five centers in the United States were included for the study. The date of the initial tisa-cel infusion was defined as the index date. A baseline period from ALL diagnosis to the index date was used to capture patient characteristics including demographics, and disease and treatment history. The study period, defined as the period from tisa-cel infusion to the end of follow-up date, i.e. the last contact date on medical charts or death, whichever was earlier, was used to capture the clinical outcomes of tisa-cel among ALL patients.

Conditions

• Acute Lymphoblastic Leukemia

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-06-18
• Completion: 2024-06-18
• First posted: 2025-06-26
• Last updated: 2025-06-26

Locations

1 site across 1 country: United States