Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Dasatinib (BMS-354825)

Inclusion Criteria:

1. Diagnosis of Ph-positive or Bcr-Abl positive CML in early chronic phase CML (i.e.,
time from diagnosis received no or minimal prior therapy, defined as <1 month of prior IFN-alpha (with or
without ara-C) and/or imatinib

2. Continued from above #1: Clonal evolution defined as the presence of additional
chromosomal abnormalities other than the Ph chromosome has been historically been
included as a criterion for accelerated phase. However, patients with clonal
evolution as the only criterion of accelerated phase have a significantly better
prognosis, and when present at diagnosis may not impact the prognosis at all. Thus,
patients with clonal evolution and no other criteria for accelerated phase will be
eligible for this study

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

4. ECOG performance of 0-2

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

6. 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.

7. 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. New York Heart Association (NYHA) cardiac class 3-4 heart disease

2. Cardiac Symptoms: Patients meeting the following criteria are not eligible unless
cleared by Cardiology: Uncontrolled angina within 3 months; Diagnosed or suspected
congenital long QT syndrome; Any history of clinically significant ventricular
arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades
de pointes); Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec) on
both the Fridericia and Bazett's correction; Uncontrolled hypertension; History of
significant bleeding disorder unrelated to cancer, including:

3. Cont: Diagnosed congenital bleeding disorders (von Willebrand's disease) Diagnosed
acquired bleeding disorder w/in 1 year (acquired anti-factor VIII antibodies);Pts
currently taking drugs that are generally accepted to have a risk of causing Torsades
de Pointes including: quinidine, procainamide, disopyramide amiodarone, sotalol,
ibutilide, dofetilide erythromycins, clarithromycin chlorpromazine, haloperidol,
mesoridazine, thioridazine, pimozide cisapride, bepridil, droperidol, methadone,
arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine,
sparfloxacin, lidoflazine.

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

5. Women of pregnancy potential must practice an effective method of birth control
during the course of the study, in a manner such that risk of failure is
minimized.Prior to study enrollment, women of childbearing potential (WOCBP) must be
advised of the importance of avoiding pregnancy during trial participation and the
potential risk factors for an unintentional pregnancy. Postmenopausal women must be
amenorrheic for at least 12 months to be considered of non-childbearing potential.

6. Continued: Women must continue birth control for the duration of the trial and at
least 3 months after the last dose of study drug; Pregnant or breast-feeding women
are excluded; All WOCBP MUST have a negative pregnancy test prior to first receiving
investigational product. If the pregnancy test is positive, the patient must not
receive investigational product and must not be enrolled in the study.

7. Patients in late chronic phase (i.e., time from diagnosis to treatment >12 months),
accelerated or blast phase are excluded.

8. The definitions of CML phases are as follows: a) Early chronic phase: time from
diagnosis to therapy 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, •Peripheral or marrow
basophils 20% or more, •Thrombocytopenia < 100 * 10^9/L unrelated to therapy, •
Documented extramedullary blastic disease outside liver or spleen.