Asciminib Treatment Optimization in ≥ 3rd Line CML-CP

Prior treatment

• Known presence of the BCR::ABL1 T315I mutation at any time prior to study entry
• Known second chronic phase of CML after previous progression to AP/BC
• Previous treatment with a hematopoietic stem-cell transplantation
• Patient planning to undergo allogeneic hematopoietic stem cell transplantation
• 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

Other illness

• Uncontrolled cardiac repolarization abnormality
• History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
• Testing for Hepatitis B surface antigen (HbsAg) and Hepatitis B core antibody (HBcAb / anti HBc) will be performed at screening. Patients with active Hepatitis B Virus (HBV) infection (hepatitis B surface antigen \[HbsAg\] positive) will be excluded
  • Other Inclusion/Exclusion criteria may apply.

• Signed informed consent must be obtained prior to participation in the study
• Male or female patients with a diagnosis of CML-CP ≥ 18 years of age
• Treatment with a minimum of 2 or more prior TKIs (i.e. imatinib, nilotinib, dasatinib, bosutinib, radotinib or ponatinib)
• Warning or failure (adapted from the 2020 ELN Recommendations) or intolerance to the most recent TKI therapy at the time of screening
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
• Adequate end organ function (as per central laboratory tests)