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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


Phase 2
N/A
18 Years
Not Enrolling
Both
Leukemia, Leukemia,Pediatric, Leukemia, Myleiod, Leukemia, Mylegenous, Chronic, Leukemia, Mylegenous, Accelerated, BCR-ABL Positive, Myeloproliferative Disorder, Bone Marrow Disease, Hematologic Diseases, Neoplastic Processes, Imatinib, Dasatinib, Enzyme Inhibitor, Protein Kinase Inhibitor

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Trial Information

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


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
normal)

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of Major Molecular Responder (MMR) by BCR-ABL RQ-PCR analysis from peripheral blood by 12 months

Outcome Description:

Newly diagnosed Ph+ CML chronic phase (CP) patient will be counted as Major Molecular Responder (MMR) by 12 months if MMR criteria is achieved at least once any time between first study drug intake and cycle 12 visit.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

European Union: European Medicines Agency

Study ID:

CAMN107A2203

NCT ID:

NCT01844765

Start Date:

June 2013

Completion Date:

October 2016

Related Keywords:

  • Leukemia
  • Leukemia,Pediatric
  • Leukemia, Myleiod
  • Leukemia, Mylegenous, Chronic
  • Leukemia, Mylegenous, Accelerated
  • BCR-ABL Positive
  • Myeloproliferative Disorder
  • Bone Marrow Disease
  • Hematologic Diseases
  • Neoplastic Processes
  • Imatinib
  • Dasatinib
  • Enzyme Inhibitor
  • Protein Kinase Inhibitor
  • Tasigna
  • nilotinib treatment
  • chronic phase
  • Ph+ CML
  • accelerated phase
  • newly diagnosed Ph+ CML
  • pediatric
  • 24 month treatment
  • Bone Marrow Diseases
  • Hematologic Diseases
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Myeloproliferative Disorders
  • Neoplastic Processes

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