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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Apr 2024

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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

    • 26 Mar 2024 According to a Nippon Shinyaku media release, based on the data from the Phase III trial conducted by Jazz Pharmaceuticals and a Phase I/II trial conducted by Nippon Shinyaku, the Ministry of Health, Labour and Welfare (MHLW) has approved Vyxeos Combination for I.V. Injection (Daunorubicin hydrochloride/cytarabine liposomal drug for injection) for the treatment of high-risk acute myeloid leukemia (AML) in Japan.
    • 12 Dec 2023 Results of a PopPKPD model analysis using data from three clinical studies: NCT00389428, NCT02238925 and NCT01696084 presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 15 Jun 2023 Results of post hoc analysis assessing 5 year trial data presented at the 28th Congress of the European Haematology Association

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