Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Accelerated Phase Who Are Refractory to Imatinib Mesylate (Gleevec)
NCT ID: NCT00041990
Last Updated: 2007-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2002-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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decitabine (5-aza-2'deoxycytidine)
Eligibility Criteria
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Inclusion Criteria
* 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 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
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
2 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Astex Pharmaceuticals, Inc.
INDUSTRY
Locations
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City of Hope Medical Center
Duarte, California, United States
Scripps Clinic
Escondido, California, United States
USC/Norris Cancer Center
Los Angeles, California, United States
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States
New York Medical College
Valhalla, New York, United States
Liberty Hematology/Oncology
Columbia, South Carolina, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Princess Margaret Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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DACO-013
Identifier Type: -
Identifier Source: secondary_id
DAC-013
Identifier Type: -
Identifier Source: org_study_id