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A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Patients With Hematological Malignancies

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Trial Profile

A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Patients With Hematological Malignancies

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 06 Oct 2023

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At a glance

  • Drugs Azacitidine (Primary) ; Azacitidine (Primary) ; Magrolimab (Primary)
  • Indications Acute myeloid leukaemia; Haematological malignancies; Myelodysplastic syndromes
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 29 Sep 2023 Status changed from active, no longer recruiting to discontinued due to futility based on the results of a planned analysis ofthe ENHANCE trial.
    • 21 Aug 2023 According to a Gilead Sciences media release, screening and enrollment of new study participants under the U.S. investigational new drug application (IND 147229) and U.S. Expanded Access Program will be paused. Patients already enrolled in AML clinical studies may continue to receive treatment and be monitored, according to the current study protocol. Global regulatory authorities and clinical trial investigators involved in the studies have been informed of the FDAs decision.
    • 21 Aug 2023 According to a Gilead Sciences media release, the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the initiation of new patients in U.S. A. sites evaluating magrolimab to treat acute myeloid leukemia. This action follows the previously announced discontinuation of the Phase 3 ENHANCE study of magrolimab in higher-risk myelodysplastic syndromes

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