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A Multi-center, Open-label, Pharmacokinetic Study of Oral Nilotinib in Pediatric Patients With Newly Diagnosed Chronic Phase (CP) Ph+ CML, With CP or Accelerated Phase (AP) Ph+ CML Resistant/Intolerant to Imatinib and/or Dasatinib, or With Refractory/Relapsed Ph+ ALL

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Trial Profile

A Multi-center, Open-label, Pharmacokinetic Study of Oral Nilotinib in Pediatric Patients With Newly Diagnosed Chronic Phase (CP) Ph+ CML, With CP or Accelerated Phase (AP) Ph+ CML Resistant/Intolerant to Imatinib and/or Dasatinib, or With Refractory/Relapsed Ph+ ALL

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 08 Nov 2021

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At a glance

  • Drugs Nilotinib (Primary)
  • Indications Chronic myeloid leukaemia; Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Pharmacokinetics
  • Sponsors Novartis

    • Most Recent Events

    • 21 Jun 2020 Results assessing growth and bone mineral density in patients with chronic myeloid leukemia, presented at the 25th Congress of the European Haematology Association.
    • 01 Nov 2019 Results assessing Pharmacokinetics of Nilotinib in pediatric patients with chronic myeloid leukemia or acute lymphoblastic leukemia were published in the Clinical Cancer Research
    • 20 Nov 2017 According to a Novartis media release, based on the results from this trial, the European Commission (EC) approved Tasigna (nilotinib) for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) and pediatric patients with Ph+ CML-CP with resistance or intolerance to prior therapy.
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