Comparison of Imatinib Versus Dasatinib in Patients With Newly-diagnosed Chronic Phase Chronic Myeloid Leukaemia

Inclusion criteria

• Male or female patients 18 years or over.
• Patients must have all of the following:

• be enrolled within 3 months of initial diagnosis of CML-CP (date of initial diagnosis is the date of first cytogenetic analysis)
• cytogenetic confirmation of the Philadelphia chromosome or variants of (9;22) translocations
• patients may have secondary chromosomal abnormalities in addition to the Philadelphia chromosome.
• < 15% blasts in peripheral blood and bone marrow;
• < 30% blasts plus promyelocytes in peripheral blood and bone marrow;
• < 20% basophils in peripheral blood,
• 100 x 109/L platelets or greater
• no evidence of extramedullary leukaemic involvement, with the exception of the hepatosplenomegaly.
• Written voluntary informed consent.

Exclusion criteria

• Patients with Ph-negative, BCR-ABL-positive, disease are NOT eligible for the study.
• Any prior treatment for CML with: any tyrosine kinase inhibitor (eg imatinib, dasatinib); busulphan; interferon-alpha; homoharringtonine; cytosine arabinoside; any other investigational agents (hydroxycarbamide and anagrelide are the only drugs permitted). NB patients will be ineligible for the study if they have received ANY prior therapy with interferon-alpha or imatinib. NO exceptions.
• Patients who received prior chemotherapy, including regimens used in peripheral blood progenitor cells (PBPCs) mobilisation for haematopoietic progenitor-cell transplantation. (It is allowable to collect unmobilised PBPCs at diagnosis.)
• Patient who have had any form of prior haemopoietic stem cell transplant, either autograft or allograft.
• Patients with an ECOG Performance Status Score of 2 or less.
• Patients with serum bilirubin, SGOT/AST, SGPT/ALT, or creatinine concentrations > 2.0 x the institutional upper limit of the normal range (IULN).
• Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) > 1.5 x IULN, with the exception of patients on treatment with oral anticoagulants.
• Patients with uncontrolled medical disease such as diabetes mellitus, thyroid dysfunction, neuropsychiatric disorders, infection, angina, or Grade 3/4 cardiac problems as defined by the New York Heart Association Criteria.
• Patients with known positivity for human immunodeficiency virus (HIV); baseline testing for HIV is not required.
• Patients who have undergone major surgery within 4 weeks of Study Day 1, or who have not recovered from prior major surgery.
• Patients who are:

• pregnant,
• breast feeding,
• of childbearing potential without a negative pregnancy test prior to Study Day 1, and
• male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
• Patients with a history of another malignancy either currently or within the past five years, with the exception of basal cell skin carcinoma or cervical carcinoma in situ.
• Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable.