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: 09 Aug 2017

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

    • 03 Aug 2017 Results published in a Jazz Pharmaceuticals media release.
    • 03 Aug 2017 According to a Jazz Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has approved Vyxeos (daunorubicin and cytarabine) liposome for injection for the treatment of adults with two types of Acute Myeloid Leukemia (AML), the submission was based on data from this trial. Vyxeos is indicated for the treatment of adults with newly-diagnosed t-AML or AML-MRC (myelodysplasia-related changes).
    • 25 Jun 2017 Results of a sub-group analysis assessing efficacy of CPX-351 or 7+3 cytarabine plus daunorubicin in patients who achieved complete remission, presented at the 22nd Congress of the European Haematology Association
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