Inclusion Criteria:

- Age ≥ 18

- Male or female patients with diagnosis of Ph+ and/or BCR-ABL+ CML

- Early chronic phase (within 6 months from diagnosis)

- Pretreatment with Hydroxyurea or Anagrelide for a duration of up to 3 months and/or
pretreatment with Imatinib for up to 30 days are permitted

- Normal serum levels of potassium, magnesium, phosphorus, total calcium corrected for
serum albumin or phosphorus, or correctable to within normal limits with supplements
prior to the first dose of study medication

- Written informed consent prior to any study procedures being performed

- AST and ALT ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to leukaemia

- Alkaline phosphatase ≤ 2.5 x ULN unless considered due to leukaemia

- Total direct bilirubin ≤ 1.5 x ULN, except know Mb. Gilbert

- Serum creatinine ≤ 1.5 x ULN

Exclusion Criteria:

- Known impaired cardiac function, including any of the following:

- LVEF < 45%

- Complete left bundle branch block

- Right bundle branch block plus left anterior hemiblock, bifascicular block

- Use of a ventricular-paced pacemaker

- Congenital long QT syndrome

- History of or presence of clinically significant ventricular or atrial
tachyarrhythmias

- Clinically significant resting bradycardia (<50 beats per minute)

- QTc>450 msec on screening ECG. If QTc > 450 msec and electrolytes are not within
normal ranges before Nilotinib dosing, electrolytes should be corrected and then the
patient rescreened for QTc criterion.

- Myocardial infarction within 12 months prior to starting study drugs

- Other clinical significant heart disease (e.g. unstable angina, congestive heart
failure, uncontrolled hypertension)

- Serum lipase and amylase > 1.5 x ULN (upper limit of normal) or history of acute
(i.e., within 1 year of starting study medication) 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 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)

- 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 (CYP3A4,
CYP2C9,andCYP2C8:link for complete list:
http://medicine.iupui.edu/flockhart/table.html..

- 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 breast feeding, 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 48 hours prior to administration of
nilotinib).

- Patients with a history of another primary malignancy that is currently clinically
significant or currently requires active intervention.

- Patients unwilling or unable to comply with the protocol