Education and Training
A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL)
This study will assess the pharmacokinetics of nilotinib in Ph+ CML pediatric patients that are newly diagnosed or resistant or intolerant to imatinib or dasatinib or refractory or relapsed Ph+ ALL compared to the adult populations. It will also evaluate safety and activity of nilotinib as secondary objectives.
Stanford is currently not accepting patients for this trial.
Intervention(s):
- drug: Nilotinib
Eligibility
Inclusion Criteria:
- Must have one of the following: newly diagnosed CP Ph+CML, CP or AP resistant/
intolerant to imatinib and/or dasatinib, or Ph+ ALL either relapsed after or
refractory to standard therapy
- adequate renal, hepatic and pancreatic function
Exclusion Criteria:
- patients receiving therapy with strong CYP3A4 inhibitors and/or inducers and
treatments cannot be stopped or changed to a different medication at least 14 days
prior to starting study drug
- patients receiving therapy with any medications with a known risk or possible risk to
prolong the QT interval and the treatment cannot be either discontinued or switched to
a different medication prior to starting study drug.
- gastrointestinal impairment or disease that may interfere with drug absorption
- liver, pancreatic or severe renal disease unrelated to disease under study
- impaired cardiac function
- patients who received dasatinib within 3 days of starting study drug
- patients who received imatinib within 5 days of starting study drug
- patients receiving hydroxyurea or corticosteroids that has not been discontinued at
least 1 week after initiation of nilotinib
- patients who received hematopoietic growth factors within 7 days of starting study
drug or Pegfilgrastim (Neulasta®) within 14 days of starting study drug
- patients with Stem Cell Transplant (SCT) or Rescue without TBI: Evidence of active
graft vs. host disease and < 3 months since SCT
Other protocol-defined inclusion/exclusion criteria may apply
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
Pediatric Hematology/Oncology
650-723-5535
Not Recruiting