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A Randomized Multicenter, Open-label, Phase 2 Study Evaluating the Efficacy and Safety of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Subjects With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly (≥ 65 Years) Acute Myeloid Leukemia (AML) Subjects Not Eligible for Hematopoietic Stem Cell Transplantation (HSCT)

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Trial Profile

A Randomized Multicenter, Open-label, Phase 2 Study Evaluating the Efficacy and Safety of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Subjects With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly (≥ 65 Years) Acute Myeloid Leukemia (AML) Subjects Not Eligible for Hematopoietic Stem Cell Transplantation (HSCT)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 14 Feb 2025

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At a glance

  • Drugs Azacitidine (Primary) ; Durvalumab (Primary)
  • Indications Acute myeloid leukaemia; Myelodysplastic syndromes
  • Focus Therapeutic Use
  • Acronyms FUSION HR MDS/ELDERLY AML 001
  • Sponsors Celgene Corporation; Celgene International SARL

    • Most Recent Events

    • 13 Dec 2022 Results comparing data from 61 TP53-M and 144 TP53 wild-type assessing Molecular, Epigenetic, and Immune Landscape of Acute Myeloid Leukemia (AML) and Higher Risk Myelodysplastic Syndromes presented at the 64th American Society of Hematology Annual Meeting and Exposition
    • 18 Aug 2022 Status changed from active, no longer recruiting to completed.
    • 28 May 2022 This trial has been completed in Portugal (Date of the global end of the trial : 27-Dec-2021), according to European Clinical Trials Database record.

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