Efficacy of Asciminib in Chronic Phase CML Patients With T315I Mutations

You may not qualify if:

• Pre-treatment with asciminib
• BCR::ABL1 variants lacking ABL1 exon a2
• 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 clinically 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)
• Known chronic pancreatitis
• 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.
• +6 more criteria