Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Blast Phase Who Are Re… (NCT00042003) | Clinical Trial Compass
CompletedPhase 2
Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Blast Phase Who Are Refractory to Imatinib Mesylate (Gleevec)
United States40 participantsStarted 2002-07
Plain-language summary
To determine the safety and efficacy of decitabine in patients with Philadelphia chromosome-positive chronic myelogenous leukemia blastic phase that were previously treated with imatinib mesylate (STI 571) and became resistant/refractory or were found to be intolerant to the drug.
Who can participate
Age range2 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 hi…