๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-02-24

A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS) (NCT05469737)

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, ONUREGยฎ) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With IPSS-R Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)

๐Ÿ”ต Active, Not Recruiting Phase2 / Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Bristol-Myers Squibb

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The purpose of this study is to evaluate the safety and efficacy of oral azacitidine in participants with low to intermediate International Prognostic Scoring System Revised (IPSS-R) myelodysplastic syndrome (MDS).

Who can join: Review the eligibility criteria below.

Location: Local Institution - 0137 โ€” Miami, Florida

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (65 Sites)

Showing the first 25 of 65 sites.

  • Local Institution - 0137 โ€” Miami, Florida
  • Local Institution - 0147 โ€” Tamarac, Florida
  • Local Institution - 0132 โ€” East Syracuse, New York
  • Local Institution - 0073 โ€” Pittsburgh, Pennsylvania
  • Local Institution - 0014 โ€” Houston, Texas
  • Local Institution - 0086 โ€” Houston, Texas
  • Local Institution - 0123 โ€” Fairfax, Virginia
  • Local Institution - 0070 โ€” Pilar, Buenos Aires
  • Local Institution - 0039 โ€” ABB, Buenos Aires F.D.
  • Local Institution - 0016 โ€” Buenos Aires,
  • Local Institution - 0022 โ€” Buenos Aires,
  • Local Institution - 0050 โ€” Buenos Aires,
  • Local Institution - 0006 โ€” Clayton, Victoria
  • Local Institution - 0018 โ€” Melbourne, Victoria
  • Local Institution - 0004 โ€” Melbourne, Victoria
  • Local Institution - 0003 โ€” Melbourne,
  • Local Institution - 0008 โ€” Toronto, Ontario
  • Local Institution - 0015 โ€” Toronto, Ontario
  • Local Institution - 0090 โ€” Montreal, Quebec
  • Local Institution - 0156 โ€” Wuhan, Hubei
  • Local Institution - 0060 โ€” Hradec Krรกlovรฉ,
  • Local Institution - 0115 โ€” Aarhus, Central Jutland
  • Local Institution - 0116 โ€” Aalborg, North Denmark
  • Local Institution - 0063 โ€” Pessac, Aquitaine
  • Local Institution - 0024 โ€” Tours, Indre-et-Loire

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—