Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.
Trial ID or NCT#
Status
Purpose
To evaluate the safety, efficacy and pharmacokinetics of nilotinib over time in the Ph+ chronic myelogenous leukemia (CML) in pediatric patients (from 1 to <18 years).
Official Title
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
Eligibility 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
- - 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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Cancer Clinical Trials Office
650-498-7061
View on ClinicalTrials.gov