Phase III, Multicenter, Randomized, Trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients 60-75 Years of Age With Untreated High Risk (Secondary) AML

Trial Profile

Phase III, Multicenter, Randomized, Trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients 60-75 Years of Age With Untreated High Risk (Secondary) AML

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 28 Feb 2018

At a glance

  • Drugs Cytarabine/daunorubicin (Primary) ; Cytarabine; Daunorubicin
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Celator Pharmaceuticals; Jazz Pharmaceuticals Inc
  • Most Recent Events

    • 08 Feb 2018 According to a Jazz Pharmaceuticals medis release, based on the data from this study, National Comprehensive Cancer Network (NCCN) Guidelines now include a Category 1 recommendation for use of Vyxeos for adult patients 60 years of age or greater with newly-diagnosed t-AML or AML-MRC.
    • 30 Jan 2018 Planned End Date changed from 1 Dec 2017 to 1 Nov 2019.
    • 12 Dec 2017 Results of subgroup analysis assessing efficacy and safety, presented at the 59th Annual Meeting and Exposition of the American Society of Hematology.
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