What this phase means
Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Asciminib single agent, Imatinib, or Nilotinib. The registry lists allocation as randomized. This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment
They plan to enroll about 347 people at 81 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment
Interventions: Asciminib single agent, Imatinib, Nilotinib, Bosutinib, Dasatinib, Asciminib single agent pediatric formulation
Primary outcome (registry wording): Number of participants with adverse events (AEs) and serious adverse events (SAEs)