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This study examines the drug Nilotinib in newly diagnosed adults with chronic-phase, Philadelphia chromosome and/or BCR-ABL positive chronic myeloid leukaemia. It enrolled patients with a cytogenetically confirmed diagnosis of chronic-phase chronic myeloid leukaemia. The study was conducted in Phase 4 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: * Patients with diagnosis of CP-CML with cytogenetic confirmation of Philadelphia (Ph) chromosome * Ph negative cases or patients with variant translocations who are BCR-ABL positive in multiplex PCR are also eligible * WHO performance status 0-2 * Laboratory assessments within normal limits * Written informed consent prior to any study procedures being performed Exclusion Criteria: * Known impaired cardiac function * History of acute or chronic pancreatitis * Impaired gastrointestinal function or disease that may alter the absorption of study drug * Concomitant medications with potential QT prolongation, or known to interact with CYP450 isoenzymes (CYP3A4, CYP2C9, and CYP2C8) * Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy * Patients who are pregnant or breast feeding, or females of reproductive potential not employing an effective method of birth control. Female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug Other protocol-defined inclusion/exclusion criteria may apply