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: 30 Aug 2017

At a glance

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

    • 23 Aug 2017 Planned End Date changed from 1 Sep 2018 to 23 Sep 2021.
    • 10 Jul 2017 According to a Bristol-Myers Squibb media release, based on the data from this trial, the U.S. FDA has accepted supplemental New Drug Application (sNDA) to include an indication for Sprycel (dasatinib) to treat children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia, as well as a powder for oral suspension (PFOS) formulation of Sprycel. The application is under priority review with an action date of November 9, 2017.
    • 25 Jun 2017 Results presented at the 22nd Congress of the European Haematology Association.
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