Clinical Trial Detail

Genders Eligible for Study: Both

- 1. CP CML within 6 months of diagnosis

--- CP-CML will be defined by (i) <15% blasts in bone marrow; (ii) <30% blasts plus promyelocytes in bone marrow; (iii) <20% basophils in peripheral blood; (iv) =/> 100 × 10^9/L platelets (=/> 100,000/mm^3); (v) No evidence of extramedullary disease except hepatosplenomegaly; AND (vi) No prior diagnosis of AP-CML or BP-CML

- 2. Cytogenetic assessment must demonstrate the BCR-ABL fusion by presence of the t(9;22) Philadelphia chromosome

--- (a)Variant translocations are only allowed provided they are assessable for cytogenetic response utilizing conventional cytogenetic techniques; (b) Conventional chromosome banding must be performed; AND (c) A minimum of 20 metaphases must be assessable at entry

- 3. ECOG Performance Status of 0, 1, or 2

- 4. Adequate hepatic function as defined by the following criteria:

--- (a) Total serum bilirubin =/< 1.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome; (b) Alanine aminotransferase (ALT) =/< 2.5 × ULN; AND (c) Aspartate aminotransferase (AST) =/< 2.5 × ULN

- 5. Adequate renal function as defined as defined by serum creatinine <1.5 x ULN

- 6. Adequate pancreatic function as defined by serum lipase and amylase =/< 1.5 × ULN

Other eligibility criteria may apply.

- 2. Received prior dasatinib therapy

- 3. Received prior nilotinib therapy

- 4. Received, for CML, any other systemic anticancer therapy, experimental therapy, or radiation therapy with the exception of anagrelide or hydroxyurea

- 5. Major surgery within 28 days prior to initiating therapy

- 6. History of bleeding disorder unrelated to CML

- 7. History of acute pancreatitis within 1 year of study or history of chronic pancreatitis

- 8. History of alcohol abuse

- 9. Have uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)

- 10. Significant uncontrolled or active cardiovascular disease, specifically including, but not restricted to:

--- (a) Myocardial infarction, unstable angina and/or congestive heart failure within 3 months prior to randomization; OR (b) History of clinically significant (as determined by the treating physician) atrial arrhythmia or any ventricular arrhythmia

- 11. Uncontrolled hypertension (diastolic blood pressure >100 mm Hg; systolic >150 mm Hg)

- 12. Taking medications that are known to be associated with Torsades de Pointes

- 13. Ongoing or active infection. The requirement for intravenous (IV) antibiotics is considered active infection

- 14. Known history of human immunodeficiency virus (HIV). Testing is not required in the absence of history

- 15. Pregnant or breastfeeding

- 16. Malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of study drugs

- 17. Diagnosed with or received anticancer therapy for another primary malignancy within 3 years prior to entry (except for non-melanoma skin cancer or cervical cancer in situ)

- 18. Any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the drug

Other exclusion criteria may apply.