A Randomized Two-Arm, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 70 mg Twice Daily or 140 mg Once Daily in Subjects with Chronic Myeloid Leukemia in Accelerated Phase or in Myeloid or Lymphoid Blast Phase or with Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia who are Resistant or Intolerant to Imatinib Mesylate.

Trial Profile

A Randomized Two-Arm, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 70 mg Twice Daily or 140 mg Once Daily in Subjects with Chronic Myeloid Leukemia in Accelerated Phase or in Myeloid or Lymphoid Blast Phase or with Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia who are Resistant or Intolerant to Imatinib Mesylate.

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Aug 2017

At a glance

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

    • 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
    • 12 Mar 2016 Results of DASISION, CA180-034 and CA180-035 trials assessing incidence of lymphocytosis and its association with response, survival, and side effects published in the Cancer
    • 14 Jun 2015 Results (from the pooled analysis of three dasatinib phase 3 clinical trials: NCT00481247, NCT00123474 and NCT00123487) presented at the 20th Congress of the European Haematology Association.
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