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This Phase 4 study assesses the rate of complete molecular response achieved with Nilotinib treatment in patients newly diagnosed with chronic-phase chronic myeloid leukemia. It included patients aged 18 and older diagnosed with Philadelphia chromosome-positive (Ph+) CML within 3 months of diagnosis. It was carried out 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.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: Patients with Ph+ CML-CP within 3 months of diagnosis. Male or female patients' ≥ 18 years of age. Patients must have adequate end organ function. Exclusion Criteria: Previously documented T315I mutation. Other CML treatment is an exclusion criteria with the following exception: While awaiting study start, patients may be treated with anagrelide (no treatment duration limit), hydroxyurea (no treatment duration limit), and/or up to a 14 day supply of a tyrosine kinase inhibitor (TKI) approved by the FDA for frontline treatment. Patients taking a TKI prior to study entry must have at least a one day washout from their last dose of medication and have recovered from any side effects of such therapy. Impaired cardiac function as defined by the protocol. Patients with contraindications to receiving nilotinib, including concomitant medications.