Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)

Exclusion Criteria

• •1. Received prior imatinib therapy
• •2. Received prior dasatinib therapy
• •3. Received prior nilotinib therapy
• •4. Received, for CML, any other systemic anticancer therapy, experimental therapy, or radiation therapy with the exception of anagrelide or hydroxyurea
• •5. Major surgery within 28 days prior to initiating therapy
• •6. History of bleeding disorder unrelated to CML
• •7. History of acute pancreatitis within 1 year of study or history of chronic pancreatitis
• •8. History of alcohol abuse
• •9. Have uncontrolled hypertriglyceridemia (triglycerides \>450 mg/dL)
• •10. Clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:
• •1. Myocardial infarction, within 6 months prior to randomization
• •2. Unstable angina within 6 months prior to randomization
• •3. Congestive heart failure within 6 months prior to randomization
• •4. History of clinically significant (as determined by the treating physician) atrial arrhythmia or any ventricular arrhythmia
• •5. Any history of ventricular arrhythmia
• •6. Cerebrovascular accident or transient ischemic attack within 6 months prior to randomization
• •7. Any history of peripheral arterial occlusive disease requiring revascularization
• •8. Any history of venous thromboembolism including deep venous thrombosis or pulmonary embolism
• •11. Uncontrolled hypertension (diastolic blood pressure \>90 mm Hg; systolic \>140 mm Hg). Patients with hypertension should be under treatment on study entry to effect blood pressure control
• •12. Taking medications that are known to be associated with Torsades de Pointes
• •13. Ongoing or active infection. The requirement for intravenous (IV) antibiotics is considered active infection
• •14. Known history of human immunodeficiency virus (HIV). Testing is not required in the absence of history
• •15. Pregnant or breastfeeding
• •16. Malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of study drugs
• •17. Diagnosed with or received anticancer therapy for another primary malignancy within 3 years prior to entry (except for non-melanoma skin cancer or cervical cancer in situ)
• •18. Any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the drug