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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 10 Jan 2022

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At a glance

  • Drugs Nilotinib (Primary)
  • Indications Chronic myeloid leukaemia
  • Focus Therapeutic Use
  • Acronyms DIALOG; DIALOGUE 1
  • Sponsors Novartis Pharmaceuticals

    • Most Recent Events

    • 14 Sep 2020 Status changed from active, no longer recruiting to completed.
    • 17 Mar 2020 Planned End Date changed from 7 Oct 2020 to 26 Aug 2020.
    • 11 Sep 2019 Results assessing efficacy and safety of nilotinib in Pediatric patients with chronic myeloid Leukemia published in the Blood

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