Frontline Asciminib Combination in Chronic Phase CML

Exclusion Criteria

• •Allogeneic stem cell transplantation
• •Known impaired cardiac function, including any of the following:
• •* Congenital long QT syndrome
• •* History of or presence of clinically significant ventricular or atrial tachyarrhythmia
• •* QTc \>450 msec on screening ECG
• •* Myocardial infarction within 12 months prior to starting therapy
• •Other clinical significant heart disease (e.g. unstable angina, congestive heart failure)
• •Acute or chronic viral hepatitis with moderate or severe hepatic impairment (Child-Pugh scores \>6), even if controlled
• •Other concurrent uncontrolled medical conditions (e.g., active or uncontrolled infections, acute or chronic liver and renal disease) that could cause unacceptable safety risks or compromise compliance with the protocol
• •Impaired gastrointestinal function or disease that may alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting and diarrhea, malabsorption syndrome, small bowel resection or gastric by-pass surgery)
• •Concomitant medications known to be strong inducers or inhibitors of the CYP450 isoenzyme CYP3A4
• •Patients who have undergone major surgery ≤2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
• •Patients who are pregnant or breastfeeding or women of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study start. Post-menopausal women must be amenorrheic for at least 12 months in order to be considered of non-childbearing potential. Male and female patients must agree to employ an effective method of birth control throughout the study and for up to 2 weeks following discontinuation of study drug
• •Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)
• •Known serious hypersensitivity reactions to asciminib, imatinib, nilotinib or dasatinib
• •Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
• •Patients unwilling or unable to comply with the protocol.