A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve (NCT03682536)
A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alpha for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) in ESA Naïve Subjects Who Require Red Blood Cell Transfusions
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dL in participants with anemia due to revised international prognostic scoring system (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require RBC transfusions and have never been exposed to erythropoiesis stimulating agent (ESA).
Who can join: Review the eligibility criteria below.
Location: Local Institution - 107 — Berkeley, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (226 Sites)
Showing the first 25 of 226 sites.
- Local Institution - 107 — Berkeley, California
- Local Institution - 115 — San Diego, California
- Local Institution - 101 — Whittier, California
- Local Institution - 104 — New Haven, Connecticut
- Local Institution - 136 — Washington D.C., District of Columbia
- Local Institution - 119 — Hudson, Florida
- Local Institution - 120 — St. Petersburg, Florida
- Local Institution - 122 — Tallahassee, Florida
- Local Institution - 108 — Tampa, Florida
- Local Institution - 118 — West Palm Beach, Florida
- Local Institution - 102 — Paducah, Kentucky
- Local Institution - 123 — Bethesda, Maryland
- Local Institution - 117 — Kansas City, Missouri
- Local Institution - 134 — East Brunswick, New Jersey
- Local Institution - 113 — Hackensack, New Jersey
- Local Institution - 105 — Greenville, North Carolina
- Local Institution - 131 — Portland, Oregon
- Univ of Pittsburgh Medical Center — Pittsburgh, Pennsylvania
- Local Institution - 111 — Rock Hill, South Carolina
- Tennessee Oncology — Nashville, Tennessee
- Baylor University Medical Center — Dallas, Texas
- Local Institution - 109 — Houston, Texas
- Local Institution - 114 — Salt Lake City, Utah
- Local Institution - 132 — Charlottesville, Virginia
- Local Institution - 127 — Chesapeake, Virginia
💰 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 § 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 — Clovis, California
- Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA — Tampa, Florida
- A Study of Tebapivat (AG-946) in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes (LR-MDS) — Lakewood, California
- Inqovi Maintenance Therapy in Myeloid Neoplasms — Boston, Massachusetts
- Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) — Birmingham, Alabama
- CPX-351 (Vyxeos™) for Transplant Eligible, Higher Risk Patients With Myelodysplastic Syndrome — Tampa, Florida
Explore by condition: All Myelodysplastic Syndromes clinical trials
💡 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.