Efficacy of 400 Mg Versus 800 Mg Imatinib in Chronic Myeloid Leukemia in Chronic Phase Patients - TOPS (Tyrosine Kinase Inhibitor Optimization and Selectivity)

Exclusion Criteria

• •Patients in late chronic phase, accelerated phase, or blastic phase are excluded
• •Patients who have received other investigational agents
• •Patients who received Gleevec/Glivec for any duration prior to study entry, with the exception of those patients successfully completing \[CSTI571A2107 (NCT00428909)\] study immediately prior to the participation in this study
• •Patient received any treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide
• •Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention
• •Patients who are: (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test prior to baseline and (d) male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial (post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
• •Patient with a severe or uncontrolled medical condition (i.e., uncontrolled diabetes,chronic renal disease)
• •Patient previously received radiotherapy to ≥ 25% of the bone marrow
• •Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery
• •Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status Score ≥ 3
• •Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) \> 1.5 x ULN, with the exception of patients on treatment with oral anticoagulants
• •Patients with known positivity for human immunodeficiency virus (HIV); baseline testing for HIV is not required
• •Patients with identified sibling donors where allogeneic bone marrow transplant is elected as first line treatment