©2022 Stanford Medicine
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: NCT01844765
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).
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
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
- Adequate renal, hepatic and pancreatic function
- Potassium, magnesium, phosphorus and total calcium values ≥ LLN (lower limit of
- 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
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office