Trial Search Results
Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.
The main purpose of this study is to learn how effective a drug called nilotinib (Tasigna®) is treating children that have either newly diagnosed Ph+CML CP or Ph+CML CP or AP that has not improved or has shown to make you too sick with a treatment called imatinib (Gleevec®/Glivec®) or dasatinib (Sprycel®).
Stanford is currently not accepting patients for this trial.
- Drug: nilotinib
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
Ages Eligible for Study
1 Year - 17 Years
Genders Eligible for Study