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

PhaseTypeAgeTrial IDs
Phase IIBiomarker/Laboratory analysis, Treatment18 and underCAMN107A2203
NCI-2014-01948, NCT01844765

Trial Description

Summary

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:

Written informed consent

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

normal)

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

Exclusion Criteria:

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, European Consortium
  • Children's Oncology Group

Trial Sites

U.S.A.

Georgia
Atlanta

Children's Healthcare of Atlanta - Egleston

Melinda Gordon Pauly
Principal Investigator

Maryland
Baltimore

Johns Hopkins University/Sidney Kimmel Cancer Center

Patrick A. Brown
Principal Investigator

North Carolina
Durham

Duke University Medical Center

Susan G. Kreissman
Principal Investigator

Tennessee
Memphis

St. Jude Children's Research Hospital

Patrick Kent Campbell
Principal Investigator

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.