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This study evaluates oral Nilotinib in pediatric patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML). It included children who were newly diagnosed or resistant/intolerant to imatinib or dasatinib. 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.
Key Inclusion Criteria: * Newly diagnosed and untreated Ph+ CML CP or Ph+ CML CP or AP resistant or intolerant to either imatinib or dasatinib * Karnofsky ≥ 50% for patients \> 10 years of age and Lansky ≥ 50 for patients ≤ 10 years of age * Adequate renal, hepatic and pancreatic function * Potassium, magnesium, phosphorus and total calcium values ≥ LLN (lower limit of normal) * Written informed consent Key Exclusion Criteria: * Treatment with strong CYP3A4 inhibitors or inducers * Use or planned use of any medications that have a known risk or possible risk to prolong the QT interval * Acute or chronic liver, pancreatic or severe renal disease * History of pancreatitis or chronic pancreatitis. * Impaired cardiac function * No evidence of active graft vs host and \<3mo since Stem Cell Transplant * Total body irradiation (TBI) or craniospinal radiation therapy \<6months * Hypersensitivity to the active ingredient or any of the excipients including lactose. * the criteria regarding pregnancy and contraception * Active or systemic bacterial, fungal, or viral infection * known Hepatitis B, Hepatitis C, or HIV infection