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A Phase 2, Multicenter, Single-Arm Bridging Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes(MDS) in Chinese and Japanese Subjects With Ring Sideroblasts Who Require Red Blood Cell Transfusions

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A Phase 2, Multicenter, Single-Arm Bridging Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes(MDS) in Chinese and Japanese Subjects With Ring Sideroblasts Who Require Red Blood Cell Transfusions

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 16 Oct 2023

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At a glance

  • Drugs Luspatercept (Primary)
  • Indications Anaemia; Myelodysplastic syndromes
  • Focus Registrational; Therapeutic Use
  • Acronyms MEDALIST
  • Sponsors Celgene Corporation

    • Most Recent Events

    • 27 Jul 2023 According to a Bristol Myers Squibb media release, based on the MEDALIST and COMMANDS studies, the Japan's Ministry of Health, Labour and Welfare accepted the New Drug Application for Reblozyl as a treatment of anemia in adult patients with MDS.
    • 01 May 2023 Status changed from recruiting to active, no longer recruiting.
    • 20 May 2022 Planned primary completion date changed from 6 Oct 2023 to 26 Aug 2023.
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