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An Open-Label, Randomized, Multicenter Phase III Trial of Dasatinib (SPRYCEL) vs. Standard Dose Imatinib (400 mg) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia

Trial Profile

An Open-Label, Randomized, Multicenter Phase III Trial of Dasatinib (SPRYCEL) vs. Standard Dose Imatinib (400 mg) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia

Completed
Phase of Trial: Phase III

Latest Information Update: 16 Jan 2019

At a glance

  • Drugs Dasatinib (Primary) ; Imatinib
  • Indications Chronic myeloid leukaemia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms DASISION
  • Sponsors Bristol-Myers Squibb
  • Most Recent Events

    • 04 Dec 2018 Results of an Indirect Comparison between Bosutinib, Nilotinib and Dasatinib in First-Line Chronic Phase CML using data from ENESTnd, DASISION and BFORE trials, presented at the 60th Annual Meeting and Exposition of the American Society of Hematology
    • 31 Aug 2018 Biomarkers information updated
    • 01 Aug 2017 Results evaluating cardiovascular ischaemic event rates in dasatinib treated patients using patient data from NCT00103701, NCT00101647, NCT00101816, NCT00101660, NCT00101595, NCT00103844, NCT00123474, NCT00123487, NCT00481247, NCT00529763, NCT01357655, NCT00744497 trials and and comparing it with external reference populations published in the Annals of Hematology
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