Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Accelerated Phase Who Are Refractory to Imatinib Mesylate (Gleevec)
To determine the safety and efficacy of decitabine in patients with Philadelphia chromosome-positive chronic myelogenous leukemia accelerated phase that were previously treated with imatinib mesylate (STI 571) and became resistant/refractory or were found to be intolerant to the drug.
|Condition or Disease||Intervention/Treatment||Phase|
Primary Outcome Measures
Histologically confirmed diagnosis of CML accelerated phase
Previous treatment with imatinib mesylate resulting in:
- 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 accelerated 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
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
Contacts and Locations
|1||City of Hope Medical Center||Duarte||California||United States|
|2||Scripps Clinic||Escondido||California||United States|
|3||USC/Norris Cancer Center||Los Angeles||California||United States|
|4||Metro-Minnesota CCOP||St. Louis Park||Minnesota||United States|
|5||New York Medical College||Valhalla||New York||United States|
|6||Liberty Hematology/Oncology||Columbia||South Carolina||United States|
|7||University of Texas MD Anderson Cancer Center||Houston||Texas||United States||77030|
|8||Princess Margaret Hospital||Toronto||Ontario||Canada|
Sponsors and Collaborators
- Astex Pharmaceuticals, Inc.
- Eisai Inc.
Study Documents (Full-Text)None provided.