ASTX727 and Dasatinib for the Treatment of Newly Diagnosed Philadelphia Chromosome or BCR-ABL Positive Chronic Myeloid Leukemia in Chronic Phase

Exclusion Criteria

• •New York Heart Association (NYHA) cardiac class 3-4 heart disease
• •* Uncontrolled angina within 3 months
• •* Diagnosed or suspected congenital long QT syndrome
• •* Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes).
• •* Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (\> 460 msec)
• •* History of significant bleeding disorder unrelated to cancer, including unless cleared by hematologist or hemato-oncologist
• •* Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
• •* Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
• •Patients with active, uncontrolled psychiatric disorders include: psychosis, major depression, and bipolar disorders
• •Subject is known to be positive for human immunodeficiency virus (HIV) (HIV testing is not required)
• •Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
• •* Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
• •* Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface \[HBs\] antigen negative-, anti-HBs antibody positive and anti-hepatitis B core \[HBc\] antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate
• •Women of pregnancy potential must practice an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized. Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Women must continue birth control for the duration of the trial and at least 3 months after the last dose of study drug.
• •Pregnant or breast-feeding women are excluded.
• •All WOCBP must have a negative pregnancy test prior to first receiving investigational product. If the pregnancy test is positive, the patient must not receive study drug and must not be enrolled in the study