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
Active, not recruiting · Phase 3 · NCT03682536
Conditions: Myelodysplastic Syndromes
At a glance
- Research payments reported, 2025
- $81,137
- U.S. investigators named
- 8
- Sites paid
- 7
- Planned or actual enrollment
- 363
About the trial
- Sponsor
- Celgene (with Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA)
- Tested
- Luspatercept (drug), Epoetin alfa (drug)
- Dates
- Started 2019-01-02; completion 2027-09-28
- Results posted
- Yes
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).
From ClinicalTrials.gov, last updated 2024-11-20. Full record, eligibility and contacts (opens in a new tab)
Industry funding
E.r. Squibb & Sons, L.l.c. reported $81,137 in research payments for this study in 2025 (8 payments).
Products named: Reblozyl
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Omkar S. Marathe, MD Hematology & Oncology · Lakewood, CA
- Firas El Chaer, M.D. Hematology · Miami, FL
- Rami S. Komrokji, M.D. Hematology · Tampa, FL
- Shachar Peles, M.D. Medical Oncology · Palm Springs, FL
- David D. Wright, MD Medical Oncology · Tampa, FL
- Bruno S. Fang, MD Hematology & Oncology · East Brunswick, NJ
- Jamie L. Koprivnikar, M.D. Medical Oncology · Hackensack, NJ
- Guillermo Garcia-manero, M.D. Hematology & Oncology · Houston, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Hackensack University Medical Center, NJ $19,382
- University of Virginia Medical Center, VA $18,965
- Titan Health PArtners Llc $15,515
- Innovative Clinical Research $10,570
- Sarah Cannon Research Institute, Llc $7,624
- Ut MD Anderson Cancer Center $4,685
- Moffitt Cancer Center $4,397
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.