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

Study Overview
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Brief Summary
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To determine the safety and efficacy of decitabine in patients with Philadelphia chromosome-positive chronic myelogenous leukemia chronic phase that were previously treated with imatinib mesylate (STI 571) and became resistant/refractory or were found to be intolerant to the drug.

Official Title
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A Phase II, Multicenter Study of Decitabine (5-aza-2'Deoxycytidine) in Chronic Myelogenous Leukemia Chronic Phase Refractory to Imatinib Mesylate (STI 571)

Conditions
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Chronic Myelogenous Leukemia

Intervention / Treatment
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* Drug: decitabine (5-aza-2'deoxycytidine)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: decitabine (5-aza-2'deoxycytidine)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic myelogenous leukemia, CML, CML-CP, Chronic phase, Decitabine, 5-aza-2'deoxycytidine, Methylation, STI 571, Imatinib mesylate, Gleevec, BCR/ABL