Trial Evaluating Nilotinib as Treatment for Newly Diagnosed CML Patients in Accelerated Phase.

Exclusion Criteria

• •Patients in Chronic and Blastic Phases.
• •Patients who are considered Ph negative because they do not have a confirmed cytogenetic diagnosis of Philadelphia Ph+ chromosome (9;22 translocation) in \> 20 metaphases.
• •Treatment with tyrosine kinase inhibitors or other antileukemic agents or treatments (including HSCT) for longer than 2 weeks, with the exception of HU and/or anagrelide
• •Previously documented T315I mutations;
• •Uncontrolled congestive heart failure or hypertension;
• •Myocardial infarction or unstable angina pectoris within past 12 months;
• •Significant arrhythmias, including history or presence of clinically significant ventricular or atrial tachyarrhythmias, clinically significant bradycardias, long QT syndrome and/or QTc \> 450 msec on screening ECG (using the QTcF formula). Patients with complete LBBB;
• •History of confirmed acute or chronic pancreatitis;
• •Other concurrent uncontrolled medical conditions (e.g. uncontrolled diabetes, 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 GI 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 bypass surgery);
• •Patients with another primary malignancy that is currently clinically significant or requires active intervention;
• •Concomitant medications with potential QT prolongation (See link for complete list: http://www.torsades.org/medical-pros/drug-lists/printable-drug-list.cfm);
• •Concomitant medications known to interact with CYP450 isoenzymes (CYP 3A4, CYP2C9, CYP2C8, (See link for complete list (http://medicine.iupui.edu/flockhart/table.htm);
• •History of significant congenital or acquired bleeding disorder unrelated to cancer;
• •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 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 nilotinib). Postmenopausal women must be amenorrheic 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 entire study and up to 3 months following discontinuation of study drug;
• •Treatment with any hematopoietic colony-stimulating growth factors (e.g. G-CSF, GM-CSF) 1 week prior to starting study drug;
• •Treatment with other investigational agents (defined as not used in accordance with the approved indication) within 30 days of Day 1;
• •Patients unwilling or unable to comply with the protocol.
• •Note: