Inclusion Criteria:

- Patients with a cytologic and cytogenetic confirmed diagnosis of Ph+ CML.

- Age ≥ 18 years old

- Early CP (within 6 months from diagnosis)

- No prior treatment with any antileukemic drugs with the exception of Hydroxyurea (HU)
and Anagrelide.

- WHO performance status of ≤ 2

- Normal serum level of potassium, total calcium corrected for serum albumin, magnesium
and phosphorus, or correctable with supplements

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

- Alkaline phosphatase ≤ 2.5 x ULN unless considered due to leukemia.

- Serum bilirubin ≤ 1.5 x ULN

- Serum creatinine ≤ 1.5 x ULN

- Serum amylase ≤ 1.5 x ULN and serum lipase ≤ 1.5 x ULN.

- Written informed consent prior to any study procedures being performed.

Exclusion criteria:

- Impaired cardiac function, including LVEF < 45% as determined by MUGA scan or
echocardiogram, uncontrolled congestive heart failure, uncontrolled hypertension

- History of myocardial infarction within three months, or uncontrolled angina
pectoris.

- Significant electric heart abnormalities, including history or presence of
significant ventricular or atrial tachyarrhythmias, congenital long QT syndrome
and/or QTc > 450 msec on screening ECG (using the QTcF formula).

- Patients with ventricular pacemakers and clinically significant bradycardias.

- Patients with heart blocks.

- History of acute or chronic pancreatitis.

- Impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of nilotinib (e.g., ulcerative diseases, uncontrolled nausea,
vomiting, diarrhea, malabsorption syndrome, or small bowel resection)

- Use of therapeutic coumarin derivates (i.e. warfarin, acenocoumarol, phenprocoumon).

- Acute or chronic liver or renal disease considered unrelated to leukaemia

- Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled
diabetes, active or uncontrolled infection) that could cause unacceptable safety
risks or compromise compliance with the protocol

- Patients who are currently receiving treatment with any of the medications listed in
Appendix E and the treatment cannot be either discontinued or switched to a different
medication prior to starting study drug. The medications listed in Appendix E have
the potential to prolong QT, with the exception of HU and Anagrelide.

- Patients who have received any antileukemic agents and treatments, including HSCT,
with the exception of HU and Anagrelide.

- Patients who have received any investigational drug ≤ 4 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 breast feeding, 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). Post menopausal 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 study and for 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.

- Patients who have received immunotherapy 1 week prior to starting study drug or who
have not recovered from side effects of such therapy.

- 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.

- Patients unwilling or unable to comply with the protocol.