Long-Term Safety Assessment and Continued Treatment with Asciminib for Patients with CML or Philadelphia-Positive ALL After Prior Novartis Study Completion

What this Trial Is About

This research evaluates the long-term safety of asciminib treatment in patients with Philadelphia chromosome-positive chronic myelogenous leukemia CML or acute lymphoblastic leukemia ALL who have completed a prior Novartis-sponsored asciminib study. It is designed to provide continued treatment for participants who, as judged by their investigator, would benefit from ongoing therapy but cannot access it outside the trial. This open-label, multi-center, global roll-over study focuses on assessing safety over an extended period. Participants receive asciminib or other related drugs such as imatinib, nilotinib, bosutinib, or dasatinib, either alone or in combination, based on their previous study treatments. Dosing varies with the specific drug for example, asciminib is taken orally once or twice daily, sometimes in fasting state, and pediatric participants receive a body weight-adjusted dose of asciminib granules. The study includes groups continuing their previous treatment, some switching from bosutinib or dasatinib to asciminib, and combinations with other tyrosine kinase inhibitors. Participants are monitored for adverse events and serious adverse events over eight years as the primary safety outcome. Secondary outcomes include clinical benefit assessments by investigators. During the study, participants undergo scheduled visits, treatment adherence tracking, and safety monitoring. The study spans from August 2022 to August 2030, allowing long-term observation of treatment effects and safety in this patient population.

Asciminib Roll-over Study