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A Phase I/Pilot Study of CPX-351 for Children, Adolescents and Young Adults With Recurrent or Refractory Hematologic Malignancies

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Trial Profile

A Phase I/Pilot Study of CPX-351 for Children, Adolescents and Young Adults With Recurrent or Refractory Hematologic Malignancies

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Cytarabine/daunorubicin (Primary)
  • Indications Acute myeloid leukaemia; Lymphoma; Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; Pharmacokinetics

    • Most Recent Events

    • 30 Mar 2021 According to a Jazz Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) approved a revised label for Vyxeos (daunorubicin and cytarabine) to include a new indication to treat newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric patients aged one year and older.The approval of Vyxeos for this indication is supported by safety data from two single-arm trials (AAML1421 and CPX-MA-1201).
    • 08 Dec 2020 Results presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology
    • 07 Oct 2019 Status changed from active, no longer recruiting to completed.

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