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This study examines the drug Dasatinib (BMS-354825) in patients with accelerated phase chronic myeloid leukemia (CML) who are resistant to or intolerant of imatinib mesylate. It enrolled patients aged 18 and older who were Philadelphia chromosome or BCR/ABL positive and had previously received imatinib. The research was conducted in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Subjects with Philadelphia chromosome positive (PH+) or the fused gene BCR/ABL positive (BCR/ABL+) accelerated phase chronic myeloid leukemia (CML) whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate. * Subjects must have had prior exposure to imatinib. However, imatinib mesylate does not need to be their most recent CML treatment prior to coming on this study. * Men and women, 18 years of age or older. * Adequate hepatic function. * Adequate renal function. * Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized. Exclusion Criteria: * Women who are pregnant or breastfeeding. * Subjects who are eligible and willing to undergo transplantation during the screening period. * A serious uncontrolled medical disorder or active infection that would impair the ability of the subjects to receive protocol therapy. * Uncontrolled or significant cardiovascular disease. * Medications that increase bleeding risk. * Medications that change heart rhythms. * Dementia or altered mental status that would prohibit the understanding or rendering of informed consent. * History of significant bleeding disorder unrelated to CML. * Concurrent incurable malignancy other than CML. * Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy. * Prior therapy with dasatinib (BMS-354825). * Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.