Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.
Basic Trial Information
|Phase II||Biomarker/Laboratory analysis, Treatment||18 and under||CAMN107A2203|
To evaluate the safety, efficacy and concentration of nilotinib over time in the Ph+ chronic
myelogenous leukemia (CML) in pediatric patients (from 1 to <18 years).
Written informed consent
Potassium, magnesium, phosphorus and total calcium values ≥ LLN (lower limit of
Adequate renal, hepatic and pancreatic function
Karnofsky or Lansky ≥ 50
Newly diagnosed and untreated Ph+ CML CP or Ph+ CML CP or AP resistant or intolerant
to either imatinib or dasatinib
Other protocol-defined inclusion/exclusion criteria.
Hypersensitivity to the active ingredient or any of the excipients including lactose.
Total body irradiation (TBI) or craniospinal radiation therapy <6months
No evidence of active graft vs host and <3mo since Stem Cell Transplant
Impaired cardiac function
History of pancreatitis or chronic pancreatitis.
Acute or chronic liver, pancreatic or severe renal disease
Use or planned use of any medications that have a known risk or possible risk to
prolong the QT interval
Treatment with strong CYP3A4 inhibitors or inducers
Trial Contact Information
Trial Lead Organizations / Sponsors / Collaborators
Novartis Pharmaceuticals Corporation
- Innovative Therapies for Children with Cancer
- Children's Oncology Group
Children's Healthcare of Atlanta - Egleston
Melinda Gordon Pauly
Duke University Medical Center
Susan G. Kreissman
St. Jude Children's Research Hospital
Patrick Kent Campbell
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01844765
Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.