Gleevec as Maintenance Therapy After Cytogenetic Response With Nilotinib in Newly Diagnosed Chronic Myelogenous Leukemia

Inclusion Criteria:

1. Newly diagnosed untreated Philadelphia chromosome-positive CML (use of hydroxyurea for <3 months is allowed) in chronic phase defined with the following criteria:

• <15% blasts in peripheral blood (PB) & bone marrow (BM)
• <30% blasts plus promyelocytes in PB & BM
• <20% basophils in PB
• ≥100 x 109/L platelets
• No evidence of extramedullary involvement, with the exception of liver & spleen

2. Patients (pts) ≥18 yrs of age
3. WHO Performance Status of ≤2
4. Pts must have the following laboratory values:

• Potassium within normal limits or corrected to within normal limits withsupplements prior to the first dose of study medication
• Total calcium (corrected for serum albumin) and magnesium within normal limits orcorrectable with supplements
• Phosphorus ≥ lower limit of normal (LLN) or correctable with supplements
• ALT and AST ≤2.5 x upper limit of normal (ULN) or ≤5.0xULN if considered due totumor
• Alkaline phosphatase ≤2.5xULN
• Serum bilirubin ≤1.5xULN
• Serum Cr ≤1.5xULN or 24-hour Cr Cl ≥50 ml/min
• Serum amylase ≤1.5xULN and serum lipase ≤1.5xULN

5. Written signed informed consent prior to any study procedures

Exclusion Criteria:

1. Cytopathologically confirmed central nervous system (CNS) infiltration
2. Impaired cardiac function, including any one of the following:

• Left ventricle ejection fraction (LVEF) <45% or below the institutional lowerlimit of the normal range (whichever is higher) as determined by MUGA scan orechocardiogram
• Complete left bundle branch block
• Use of a pacemaker
• ST depression of >1mm in 2 or more leads and/or T wave inversions in 2 or morecontiguous leads
• Congenital long QT syndrome
• History of or presence of significant ventricular or atrial tachyarrhythmias
• Clinically significant resting bradycardia (<50 beats/min)
• QTc >450 msec on screening ECG
• Right bundle branch block plus left anterior hemiblock, bifascicular block
• Myocardial infarction within 12 months prior to starting nilotinib
• Unstable angina diagnosed or treated during the past 12 months
• Other clinically significant heart disease (e.g., congestive heart failure,uncontrolled hypertension, or history of labile hypertension)

3. Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol) up to daybefore study drug administration
4. Acute or chronic liver or renal disease considered unrelated to tumor such as activeHepatitis A, B, or C
5. Other concurrent severe and/or uncontrolled medical conditions
6. Pts who are currently receiving treatment with any of the medications that have thepotential to prolong QT interval
7. Pts who have received any investigational drug ≤4 weeks or investigational cytotoxicagent within 1 week (or who are within 5 half-lives of a previous investigationalcytotoxic agent) prior to starting study drug or who have not recovered from sideeffects of such therapy
8. Pts who have received wide field radiotherapy ≤4 weeks or limited field radiation forpalliation <2 weeks prior to starting study drug or who have not recovered from sideeffects of such therapy
9. Pts who have undergone major surgery ≤2 weeks prior to starting study drug or who havenot recovered from side effects of such therapy
10. Known diagnosis of HIV
11. Pt with a history of another malignancy that is currently clinically significant orcurrently requires active intervention
12. Pts who are pregnant or breast feeding, or adults of reproductive potential notemploying an effective method of birth control (women of childbearing potential musthave a negative serum pregnancy test within 48 hrs prior to drug administration). Postmenopausal women must be amenorrheic for at least 12 months. Male & female pts mustagree to employ an effective method of birth control throughout the study and for 3months following discontinuation of study drug
13. Pts unwilling or unable to comply with protocol