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)
๐ฉบ 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
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ 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
๐ฐ 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.
More studies in Myelodysplastic Syndromes
- ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions โ Clovis, California
- Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA โ Tampa, Florida
- A Study of Tebapivat (AG-946) in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes (LR-MDS) โ Lakewood, California
- Inqovi Maintenance Therapy in Myeloid Neoplasms โ Boston, Massachusetts
- Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) โ Birmingham, Alabama
- CPX-351 (Vyxeosโข) for Transplant Eligible, Higher Risk Patients With Myelodysplastic Syndrome โ Tampa, Florida
Explore by condition: All Myelodysplastic Syndromes clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.