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.

Lead Sponsor:

Novartis Pharmaceuticals

Collaborator: Innovative Therapies For Children with Cancer Consortium

Intervention(s):

  • Drug: nilotinib

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Newly diagnosed and untreated Ph+ CML CP or Ph+ CML CP or AP resistant or intolerant
   to either imatinib or dasatinib

   - Karnofsky or Lansky ≥ 50

   - Adequate renal, hepatic and pancreatic function

   - Potassium, magnesium, phosphorus and total calcium values ≥ LLN (lower limit of
   normal)

   - Written informed consent

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.

   - Other protocol-defined inclusion/exclusion criteria.

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