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

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and underCAMN107A2203
NCI-2014-01948, NCT01844765

Trial Description


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).

Eligibility Criteria

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


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.

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Novartis Pharmaceuticals Corporation

  • Childrens Oncology Group
  • Innovative Therapies For Children with Cancer Consortium

Link to the current record.
NLM Identifier NCT01844765

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