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A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL)
Not Recruiting
Trial ID: NCT01077544
Purpose
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.
Official Title
A Multi-center, Open-label, Pharmacokinetic Study of Oral Nilotinib in Pediatric Patients With Newly Diagnosed Chronic Phase (CP) Ph+ CML, With CP or Accelerated Phase (AP) Ph+ CML Resistant/Intolerant to Imatinib and/or Dasatinib, or With Refractory/Relapsed Ph+ ALL
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
Intervention(s):
drug: Nilotinib
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Pediatric Hematology/Oncology
650-723-5535