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)

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)

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 06 Dec 2017

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
  • Most Recent Events

    • 30 Nov 2017 Planned primary completion date changed from 11 Feb 2018 to 26 May 2018.
    • 30 Nov 2017 Status changed from recruiting to active, no longer recruiting.
    • 06 Jun 2017 Trial design presented at the 53rd Annual Meeting of the American Society of Clinical Oncology
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