Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Oral Nilotinib

Inclusion Criteria:

1. Diagnosis of Ph-positive or Bcr-positive CML in early chronic phase CML (i.e., time
from diagnosis 12 months). Except for hydroxyurea, patients must have received no or
minimal prior therapy, defined as <1 month of prior interferon-alpha (with or without
cytarabine) and/or an FDA-approved TKI. Patients with de novo accelerated phase will
be treated but analyzed separately.

2. Age >/= 16 years (Age >18 years to participate in optional symptom burden assessment)

3. ECOG performance of 0-2.

4. Adequate end organ function, defined as the following: total bilirubin < 1.5 x ULN,
SGPT < 2.5 x ULN, creatinine < 1.5 x ULN.

5. Patients must sign an informed consent indicating they are aware of the
investigational nature of this study, in keeping with the policies of the hospital.

6. Reliable telephone access to receive calls from an interactive voice response system
(IVR) (only applicable to patients who will participate in optional symptom burden
assessment).

Exclusion Criteria:

1. NYHA cardiac class 3-4 heart disease as well as impaired cardiac function defined as:
LVEF < 45% as determined by MUGA scan or electrocardiogram; Complete left bundle
branch block; Use of cardiac pacemaker; ST depression of > 1 mm in 2 or more leads
and/or T wave inversions in 2 or more continuous leads; Congenital long QT syndrome;
History of, or presence of significant ventricular or atrial tachyarrhythmia's;
Clinically significant resting bradycardia (< 50 bpm); QTc > 450 msec on screening
ECG (using the QTcF formula);

2. (Continued from #1) Right bundle branch block plus left anterior hemiblock,
bivascular block; Myocardial infarction within 12 months prior to starting AMN107;
Unstable angina diagnosed or treated within the past 12 months; Other clinically
significant heart disease (e.g. congestive heart failure, uncontrolled hypertension,
history of labile hypertension, or history of poor compliance with an
antihypertensive regimen).

3. Patients with active, uncontrolled psychiatric disorders including: psychosis, major
depression, and bipolar disorders.

4. Female patients of childbearing potential must have negative pregnancy test within 7
days before initiation of study drug dosing. Postmenopausal women must be amenorrheic
for at least 12 months to be considered of non-childbearing potential. Surgical
sterilization is considered non-childbearing potential. Female patients of
reproductive potential must agree to employ an effective method of birth control
(hormonal or barrier) throughout the study and for up to 3 months following
discontinuation of study drug.

5. Patients with severe and/or uncontrolled medial disease (i.e., uncontrolled diabetes,
chronic renal disease, or active uncontrolled infection [persistent fever and
worsening clinical condition]).

6. Patient with known chronic liver disease (i.e., chronic active hepatitis, and
cirrhosis).

7. Patient with known diagnosis of human immunodeficiency virus (HIV) infection.

8. Patients in late chronic phase (i.e., time from diagnosis to treatment >12 months) or
blastic phase are excluded. The definitions of CML phases are as follows: A. Early
chronic phase: time from diagnosis to therapy < 12 months Late chronic phase: time
from diagnosis to therapy > 12 months.B. Blastic phase: presence of 30% blasts or
more in the peripheral blood or bone marrow. C. Accelerated phase CML: presence of
any of the following features: * Peripheral or marrow blasts 15% or more.

9. (Cont. #8)Peripheral or marrow basophils 20% or more. *Thrombocytopenia < 100 x
10(9)/L unrelated to therapy. * Documented extramedullary blastic disease outside
liver or spleen due to past causes D. Clonal evolution defined as the presence of
additional chromosomal abnormalities other than the Ph chromosome is part of
accelerated phase CML. Ph chromosome variants or complex Ph chromosome translocations
are not considered to indicate disease acceleration.

10. ( Cont # 8) We have recently found clonal evolution to have a variable prognostic
impact and may be suppressed with IFN-a therapy. Hence these patients, like others
with de novo accelerated phase, will be eligible, and analyzed separately.