A Phase II, Multicenter Study of Decitabine (5-aza-2'Deoxycytidine) in Chronic Myelogenous Leukemia Chronic Phase Refractory to Imatinib Mesylate (STI 571)
Inclusion Criteria
Inclusion:
- Histologically confirmed diagnosis of CML chronic 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
chronic 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