Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.

Not Recruiting

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).

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

Stanford Investigator(s)


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

   - 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


drug: nilotinib

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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