jRCT2080222210CompletedPhase 2
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
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Novartis Pharma
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- -
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Intervention Model
- Single Arm, Open Label, Multi-center
- Primary Purpose
- Treatment Purpose
Eligibility Criteria
- Ages
- 1age old over to 17age old under (—)
- Sex
- All
Inclusion Criteria
- •Male or female patients from 1 year of age to less than 18 years of age at study entry
- •Patients must have the diagnosis of newly diagnosed Ph+ CML-CP or Ph+CML-CP or AP resistant or intolerant to either imatinib or dasatinib
- •Performance status: Karnofsky >= 50% for patients > 10 years of age, and Lansky >= 50 for patients <= 10 years of age
- •Patients must have adequate renal, hepatic and pancreatic function
- •Patients must have potassium, magnesium, phosphorus and total calcium values >= LLN (lower limit of normal) or corrected to within normal limits with supplements prior to the first dose of study medication
- •Written informed consent must be obtained prior to any screening procedures
Exclusion Criteria
- •Patients actively receiving therapy with strong CYP3A4 inhibitors or inducers and the treatment cannot be either discontinued or switched to a different medication at least 14 days prior to starting study drug.
- •Patients who are currently receiving treatment with any medications that have 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.
- •Acute or chronic liver, pancreatic or severe renal disease considered unrelated to CML.
- •History of pancreatitis within 12 months of starting study drug or past medical history of chronic pancreatitis.
- •In case of Stem Cell Transplant (SCT) or Rescue without total body irradiation (TBI): Evidence of either active graft vs. host disease or less than 3 months since SCT.
- •Patients who have a known hypersensitivity to the active ingredient or any of the excipients including lactose.
Outcomes
Primary Outcomes
-
efficacy -
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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