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This study evaluates the drug Omacetaxine Mepesuccinate (Homoharringtonine) in Chronic Myeloid Leukemia (CML) patients carrying the T315I mutation in the BCR-ABL gene. It included Philadelphia chromosome-positive patients over 18 who had failed prior imatinib therapy. It was a Phase 2 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Male or female patients, age 18 years or older * Philadelphia chromosome (Ph) positive chronic myelogenous leukemia in either chronic, accelerated, or blast phase * The patient will have the T315I BCR-ABL gene mutation * Patients will have failed prior imatinib therapy * ECOG performance status 0-2 Exclusion Criteria: * NYHA class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia and requiring therapy, uncontrolled hypertension or congestive heart failure * Myocardial infarction in the previous 12 weeks * Lymphoid Ph+ blast crisis