A multi-center, open label, non-controlled phase II study to evaluate efficacy and safety of oral nilotinib in pediatric patients with newly diagnosed Ph+ chronic myelogenous leukemia (CML) in chronic phase (CP) or with Ph+ CML in CP or accelerated phase (AP) resistant or intolerant to either imatinib or dasatinib

Novartis Pharma1 个研究点目标入组 70 人开始时间: 待定最近更新: 2021年12月20日

适应症

试验速览

暂无简介。

•Male or female patients from 1 year of age to less than 18 years of age at study entry
•Patients must have the diagnosis of newly diagnosed Ph+ CML-CP or Ph+CML-CP or AP resistant or intolerant to either imatinib or dasatinib
•Performance status: Karnofsky >= 50% for patients > 10 years of age, and Lansky >= 50 for patients <= 10 years of age
•Patients must have adequate renal, hepatic and pancreatic function
•Patients must have potassium, magnesium, phosphorus and total calcium values >= LLN (lower limit of normal) or corrected to within normal limits with supplements prior to the first dose of study medication
•Written informed consent must be obtained prior to any screening procedures

•Patients actively receiving therapy with strong CYP3A4 inhibitors or inducers and the treatment cannot be either discontinued or switched to a different medication at least 14 days prior to starting study drug.
•Patients who are currently receiving treatment with any medications that have a known risk or possible risk to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug.
•Acute or chronic liver, pancreatic or severe renal disease considered unrelated to CML.
•History of pancreatitis within 12 months of starting study drug or past medical history of chronic pancreatitis.
•In case of Stem Cell Transplant (SCT) or Rescue without total body irradiation (TBI): Evidence of either active graft vs. host disease or less than 3 months since SCT.
•Patients who have a known hypersensitivity to the active ingredient or any of the excipients including lactose.

efficacy -

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