Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Blast Phase Who Are Refractory to Imatinib Mesylate (Gleevec)

Inclusion Criteria

• •Inclusion:
• •Histologically confirmed diagnosis of CML blast phase
• •Ph chromosome-positive
• •Previous treatment with imatinib mesylate resulting in: i) Hematologic Resistance / Hematologic Refractory: Based on a physician's (documented) decision to discontinue imatinib mesylate treatment due to failure of continued benefit or no benefit to the patient, ii) Imatinib Mesylate Intolerance: any toxicity resulting in a physician's (documented) decision to discontinue imatinib mesylate treatment.
• •Patients must have recovered from the side effects of previous CML therapy for blast phase with the exception of hydroxyurea
• •Age \>/= 2 years
• •Bilirubin \</= 3 x the upper limit of normal (ULN), SGOT and SGPT \</= 3 x ULN, except \</= 5 x ULN in leukemic involvement of the liver, serum creatinine \</= 2 x ULN
• •WHO performance status 0-3
• •A negative serum hCG pregnancy test in patients of childbearing potential
• •Able to give signed informed consent directly or through a parent or guardian for minors
• •Exclusion:
• •Leukemic involvement of the central nervous system
• •Active malignancy other than CML or non-melanoma cancer of the skin
• •Previous treatment for CML with another investigational agent within 28 days of study entry
• •At study entry, patients who were treated with: imatinib mesylate within the past 48 hours, interferon-alpha within the past 48 hours; homoharringtonine within the past 14 days; low-dose cytosine arabinoside within 7 days, moderate dose within 14 days, or high dose within 28 days; etoposide, anthracyclines, or mitoxantrone within 21 days; busulfan within the past six weeks
• •Patients who had received hematopoietic stem cell transplantation within 6 weeks of Day 1 decitabine therapy
• •Patients with Grade 3/4 cardiac disease or any other serious concurrent medical condition.
• •Patients who are pregnant or nursing. All patients of childbearing potential must practice effective methods of contraception while on study.
• •Patients with mental illness or other condition precluding their ability to give informed consent or to comply with study requirements
• •Patients with systemic, uncontrolled infections