A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase CML or With Ph+ Leukemias Resistant or Intolerant to Imatinib

Trial Profile

A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase CML or With Ph+ Leukemias Resistant or Intolerant to Imatinib

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 19 Jun 2018

At a glance

  • Drugs Dasatinib (Primary) ; Dasatinib (Primary)
  • Indications Chronic myeloid leukaemia; Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Registrational; Therapeutic Use
  • Sponsors Bristol-Myers Squibb
  • Most Recent Events

    • 02 Mar 2018 Results published in the Journal of Clinical Oncology
    • 10 Nov 2017 According to a Bristol-Myers Squibb media release, based on the data from this trial, the U.S. FDA has approved dasatinib (Sprycel) for the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
    • 23 Aug 2017 Planned End Date changed from 1 Sep 2018 to 23 Sep 2021.
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