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A Phase 1/2 Study of CPX-351 (NSC# 775341) Alone Followed by Fludarabine, Cytarabine, and G-CSF (FLAG) for Children With Relapsed Acute Myeloid Leukemia (AML)

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Trial Profile

A Phase 1/2 Study of CPX-351 (NSC# 775341) Alone Followed by Fludarabine, Cytarabine, and G-CSF (FLAG) for Children With Relapsed Acute Myeloid Leukemia (AML)

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 12 Sep 2023

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At a glance

  • Drugs Cytarabine/daunorubicin (Primary) ; Cytarabine; Cytarabine; Filgrastim; Filgrastim; Fludarabine
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions; Therapeutic Use

    • Most Recent Events

    • 01 Aug 2023 Status changed from active, no longer recruiting to completed.
    • 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).
    • 31 May 2020 Results presented at the 56th Annual Meeting of the American Society of Clinical Oncology.
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