De Novo Adult Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Patients

Exclusion Criteria

• •Impaired cardiac function, including any one of the following:
• •* LVEF \<45% as determined by MUGA scan or echocardiogram.
• •* Complete left bundle branch block.
• •* Use of a cardiac pacemaker.
• •* ST depression of \>1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads.
• •* Congenital long QT syndrome.
• •* History of or presence of significant ventricular or atrial arrhythmia.
• •* Clinically significant resting bradycardia (\<50 beats per minute).
• •* QTc \>450 msec on screening ECG (using the QTcF formula).
• •* Right bundle branch block plus left anterior hemiblock, bifascicular block.
• •* Myocardial infarction within 3 months prior to starting Dasatinib.
• •* Angina pectoris.
• •* Other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen).
• •Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Dasatinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
• •Use of therapeutic warfarin.
• •Acute or chronic liver or renal disease considered unrelated to leukemia.
• •Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol.
• •Active uncontrolled systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
• •Treatment with any hematopoietic colony-stimulating growth factors (e.g., G-CSF, GMCSF) ≤1 week prior to starting study drug.
• •Patients who are currently receiving treatment with any of the medications listed in "Appendix H" and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. The medications listed in "Appendix H" have the potential to prolong the QT interval.
• •Patients who have received any antileukemic agents and treatments including steroids. for more than 14 days including 7 days pretreatment that is part of the protocol.
• •Patients who have received any investigational drug in the last 2 weeks.
• •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 adults of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of Dasatinib. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
• •Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory).
• •Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention.
• •Non compliant to oral medication patients.
• •Significant pleural effusion on baseline chest X-Ray (CXR) or pericardial effusion on baseline echocardiogram.
• •Use of H2 blockers or proton pump inhibitors.