For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

1. Signed Written Informed Consent

1. Patients must be informed of the investigational nature of this study and of
alternative standard therapeutic options and must provide written informed
consent

2. Target Population

1. Men and women diagnosed with Chronic Phase Chronic Myeloid Leukemia (CP-CML), on
treatment with Dasatinib for a minimum of 2 years at the time of enrollment and
in Dasatinib-induced complete molecular remission (CMR defined as ≤ 0.0032% or
4.5 log reduction of BCR-ABL transcript from standardized baseline) ongoing for
at least 1 year prior to study entry

- Patients are eligible for the screening assessment from the central lab if
they have been in stable Dasatinib induced CMR for a minimum of nine months,
documented by at least three assessments, conducted 2.5 - 3.5 months apart, at a
local lab. The first screening assessment conducted at the central lab will be
repeated after three months, if the first assessment confirms CMR (MR 4.5).
Patients are eligible for enrollment if both assessments from the central lab
confirm MR4.5

2. Patients with CP CML treated with Dasatinib as first line treatment or patients
with CP CML receiving Dasatinib in second line treatment after a tyrosine-kinase
inhibitor (TKI)-based therapy

3. BCR-ABL transcript ratio ≤10% after 3 months from the beginning of Dasatinib
treatment (either as first or second line treatment)

4. Eastern Co-Operative Group (ECOG) Performance Status (PS) of 0-1

5. Life expectancy of >1 year

6. Adequate renal function defined as serum creatinine ≤3.0 times the institutional
ULN

7. Adequate hepatic function defined as: total bilirubin ≤2.0 times the
institutional ULN; alanine aminotransferase (ALT) and aspartate aminotransferase
(AST) ≤2.5 times the institutional upper limit of normal (ULN)

8. Serum Na, K, Mg, and total serum Ca or ionized Ca levels must be greater than or
equal to the institutional lower limit of normal. Patients with low K, Mg
levels, total serum Ca and/or ionized Ca must be replete to allow for protocol
entry

3. Reproductive Status

1. Women of childbearing potential (WOCBP) must use method(s) of contraception
throughout the entire study period (ie during the study periods of Dasatinib
discontinuation and during re-initiation of Dasatinib). For a teratogenic study
drug and/or when there is insufficient information to assess teratogenicity
(preclinical studies have not been done), a highly effective method(s) of
contraception (failure rate of less than 1% per year) is required. The
individual methods of contraception and duration should be determined in
consultation with the investigator. WOCBP must follow instructions for birth
control when the half life of the investigational drug is less than 24 hours,
contraception should be continued throughout the study period and in case of
treatment discontinuation for a period of 30 days after the last dose of
investigational product

2. Women must have a negative serum or urine pregnancy test (minimum sensitivity 25
IU/L or equivalent units of HCG) within 72 hours prior to study entry, at each
study visit, and 72 hours prior to re-initiation of Dasatinib

3. Women must not be breastfeeding

4. Men who are sexually active with WOCBP must use any contraceptive method with a
failure rate of less than 1% per year. The investigator shall review
contraception methods and the time period that contraception must be followed.
Men that are sexually active with WOCBP must follow instructions for birth
control when the half life of the investigational drug is less than 24 hours,
contraception should be continued for a period of 90 days after the last dose of
investigational product

5. Women who are not of childbearing potential (ie, who are postmenopausal or
surgically sterile) and azoospermic men do not require contraception

Exclusion Criteria:

1. Target Disease Exceptions

a) Subjects with more than one CML treatment before Dasatinib b) BCR-ABL transcript
ratio >10% after 3 months from the beginning of Dasatinib treatment (either as first
or second line treatment) c) Patients who have previously undergone hematopoietic
stem cell transplantation (SCT) or who are scheduled for SCT d) Any prior treatment
with interferon e) Previous diagnosis of CML accelerated phase or blast crisis

2. Medical History and Concurrent Diseases

1. Prior or concurrent malignancy, except the following:

- Curatively treated basal cell or squamous cell skin cancer

- Cervical carcinoma in situ

- Adequately treated Stage I or II cancer from which the subject is currently in
complete remission

- Any other cancer from which the subject has been disease free for 3 years

2. A serious uncontrolled medical disorder or active infection that would impair
the ability of the subject to receive protocol therapy

3. Uncontrolled or significant cardiovascular disease, including any of the
following:

- Congestive cardiac failure (NYHA >2) within 3 months

- Diagnosed or suspected congenital long QT syndrome

- Any history of clinically significant ventricular arrhythmias

- Prolonged QTc interval on pre-entry electrocardiogram (>450 msec)

- Any history of second or third degree heart block (may be eligible if the
subject currently has a pacemaker)

- Uncontrolled angina within 3 months

- Prior myocardial infarction within 6 months

- Uncontrolled hypertension

4. Pulmonary arterial hypertension

5. Subjects with pericardial effusion of any grade at study entry are excluded.
Subjects previously diagnosed with pleural/pericardial effusion of any grade
resolved at the time of study entry are allowed

6. History of significant bleeding disorder unrelated to CML, including

- Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)

- Diagnosed acquired bleeding disorder within one year (e.g., acquired
anti-factor VIII antibodies)

3. Physical and Laboratory Test Findings a) Included above

4. Allergies and Adverse Drug Reaction

a) Subjects with known hypersensitivity to excipients of Dasatinib tablets (Tablet
core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium;
hydroxypropyl cellulose, magnesium stearate; Film-coating: hypromellose titanium
dioxide macrogol 400)

5. Sex and Reproductive Status

1. Patients with a history of non-compliance to CML treatment and monitoring
requirements

2. Patients who are pregnant or breastfeeding or likely to become pregnant

3. Men whose partner is unwilling or unable to avoid pregnancy

6. Other Exclusion Criteria a) Prisoners or subjects who are involuntarily incarcerated