Open-label Study of Asciminib for CML-CP or CML-AP Patients With T315I Mutation Who Are Resistant, Intolerant or Ineligible to Ponatinib.

Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Male or female participants with a diagnosis of CML-CP or CML-AP ≥ 18 years of age. * Patients with CML-CP or CML-AP with history of documented T315I mutation after at least one TKI and are resistant, intolerant, or ineligible to ponatinib (according to Investigator judgment) * Not already treated with asciminib or another any allosteric TKI * Failure (adapted from the 2020 \& 2013 ELN Guidelines) or intolerance to Ponatinib at the time of Screening. * Ineligible to ponatinib according to Investigator (based on EU ponatinib SmPC) * Evidence of typical BCR::ABL1 transcript or atypical transcripts at the time of Screening which are amenable to standardized or non-standardized RQ-PCR quantification. Exclusion Criteria: * Previous hematopoietic allogeneic stem-cell transplantation * Cardiac or cardiac repolarization abnormality * Severe and/or uncontrolled concurrent medical disease that in the opinion of the Investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes, active or uncontrolled infection, pulmonary hypertension) * History of clinical acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis (except if ponatinib-induced and completely resolved at time of Screening) * History of acute or chronic liver disease (i.e., cirrhosis; liver impairment) * Known presence of si…