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

Completed

Conditions studied: Acute Lymphoblastic Leukemia

In brief

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.

Key facts

Study ID

NCT07039383

Run by

Novartis Pharmaceuticals

People needed

79

Starts

2023-03-01

Expected to finish

2024-06-18

Last updated by the study team

2025-06-26

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with B-cell ALL.
• Infusion of tisa-cel happened since December 2020 and at least 1 year before the chart abstraction date.
• Exclusion criteria: None.

Where it is running

• Novartis — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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