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A Phase 2/3, Multicenter, Randomized, Dose Optimization (Part I), Double-blind (Part II) Study to Compare the Efficacy and Safety of Oral Azacitidine (Oral-Aza, ONUREG) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With IPSS-R Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)

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Trial Profile

A Phase 2/3, Multicenter, Randomized, Dose Optimization (Part I), Double-blind (Part II) Study to Compare the Efficacy and Safety of Oral Azacitidine (Oral-Aza, ONUREG) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With IPSS-R Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)

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

Latest Information Update: 15 Oct 2025

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At a glance

  • Drugs Azacitidine (Primary) ; Antineoplastics
  • Indications Myelodysplastic syndromes
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ASTREON
  • Sponsors Bristol-Myers Squibb; Celgene Corporation

Most Recent Events

  • 04 Jun 2024 Results (n= 47, As of December 4, 2023) assessing safety and preliminary efficacy data from phase 2 of the ASTREON study, which evaluated 14-day Oral-AZA regimens in pts with Low-/Int-risk MDS were presented at the 60th Annual Meeting of the American Society of Clinical Oncology.
  • 07 May 2024 Status changed from recruiting to active, no longer recruiting.
  • 15 Jun 2023 Trial design presented at the 28th Congress of the European Haematology Association.

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