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

Trial ID or NCT#

NCT01844765

Status

not recruiting iconNOT RECRUITING

Purpose

To evaluate the safety, efficacy and pharmacokinetics of nilotinib over time in the Ph+ chronic myelogenous leukemia (CML) in pediatric patients (from 1 to \<18 years).

Official Title

A Multi-center, Open Label, Non-controlled Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Pediatric Patients With Newly Diagnosed Ph+ Chronic Myelogenous Leukemia (CML) in Chronic Phase (CP) or With Ph+ CML in CP or Accelerated Phase (AP) Resistant or Intolerant to Either Imatinib or Dasatinib

Eligibility Criteria

Ages Eligible for Study: 1 Year to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * Newly diagnosed and untreated Ph+ CML CP or Ph+ CML CP or AP resistant or intolerant to either imatinib or dasatinib* Karnofsky ≥ 50% for patients \> 10 years of age and Lansky ≥ 50 for patients ≤ 10 years of age* Adequate renal, hepatic and pancreatic function* Potassium, magnesium, phosphorus and total calcium values ≥ LLN (lower limit of normal)* Written informed consent
    1. Key
Exclusion Criteria:
  1. * 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.* the criteria regarding pregnancy and contraception* Active or systemic bacterial, fungal, or viral infection* known Hepatitis B, Hepatitis C, or HIV infection
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Investigator(s)

Kara Davis
Neyssa Marina

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Contact

Cancer Clinical Trials Office
650-498-7061

View on ClinicalTrials.gov