Efficacy and Safety of Nilotinib Patients With Newly Diagnosed CML - CP (Chronic Myelogenous Leukemia - Chronic Phase)

Inclusion criteria:

1. Male or female patients ≥ 18 years of age.

2. ECOG 0, 1, or 2.

3. Patients with Ph+ CML who have failed treatment in the core protocol.

4. Diagnosis of chronic myelogenous leukemia with cytogenetic confirmation ofPhiladelphia chromosome of (9;22) translocations (presence of BCR-ABL a review of aminimum 20 metaphases is required).

5. Adequate end organ function as defined by:

• Total bilirubin < 1.5 x ULN,

• SGOT and SGPT < 2.5 x ULN,

• Creatinine < 1.5 x ULN,

• Serum amylase and lipase ≤ 1.5 x ULN,

• Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related.

6. Patients must have the following laboratory values (≥ LLN (lower limit of normal) orcorrected to within normal limits with supplements prior to the first dose of studymedication.):

• Potassium ≥ LLN,

• Magnesium ≥ LLN,

• Phosphorus ≥ LLN,

• Total calcium (corrected for serum albumin) ≥ LLN.

Exclusion criteria:

1. Previously documented T315I mutations.

2. Impaired cardiac function including any one of the following:

• LVEF < 45% or below the institutional lower limit of the normal range (whicheveris higher) as determined by locally read echocardiogram.

• Inability to determine the QT interval on ECG.

• Complete left bundle branch block.

• Use of a ventricular-paced pacemaker.

• Congenital long QT syndrome or a known family history of long QT syndrome.

• History of or presence of clinically significant ventricular or atrialtachyarrhythmias.