Gene Therapy Clinical Trials
Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.
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).
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: nilotinib
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
Ages Eligible for Study
1 Year - 17 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting