Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2

- First cytogenetic diagnosis of CML-CP with cytogenetic confirmation of Philadelphia
chromosome of (9;22) translocations within 6 months. Standard conventional
cytogenetic analysis must be performed.

- Previously untreated for CML, except for hydroxyurea and/or anagrelide (except
imatinib treatment for max. 31 days long)

- Adequate end organ function with following laboratory criteria: total bilirubin < 1.5
x upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) < 2.5 x upper limit of normal (ULN); creatinine < 1.5 x upper
limit of normal (ULN); serum amylase and lipase ≤ 1.5 x upper limit of normal (ULN);
alkaline phosphatase ≤ 2.5 x upper limit of normal (ULN) unless considered tumor
related

- Serum potassium, magnesium, and phosphorus levels are equal or above the lower limit
of normal prior to the first dose of study medication

Exclusion Criteria:

- Treatment with tyrosine kinase inhibitor(s) prior to study (in emergent cases where
the patient requires disease management while awaiting study start, commercial
supplies of imatinib at any dose may be prescribed to the patient but for no longer
than 31 days in duration)

- Known cytopathologically confirmed Central Nervous System CNS infiltration

- Impaired cardiac function

- Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or
uncontrolled infection)

- Acute or chronic liver, pancreatic or severe renal disease considered unrelated to
disease

- Patients with another primary malignancy except if the other primary malignancy is
neither currently clinically significant or requiring active intervention

- History of significant congenital or acquired bleeding disorder unrelated to cancer

- Previous radiotherapy to ≥25% of the bone marrow

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

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

- Patients actively receiving therapy with strong Cytochrome P450 3A4 isoenzyme
(CYP3A4) inhibitors (e.g, erythromycin, ketoconazole, itraconazole, voriconazole,
clarithromycin, telithromycin, ritonavir, mibefradil)

- Patients actively receiving therapy with medications that have the potential to
prolong the QT interval and the treatment cannot be either discontinued or switched
to a different medication prior to starting study drug

Other protocol-defined inclusion/exclusion criteria may apply