🏛️ Verified NIH Record • Updated 2024-11-04

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

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Celgene

🩺 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 Checklist

Full 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.

💡 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.
🏛️ View Official NIH Record ↗