Myeloid and Monocytic Leukemia, Phase III
A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) vs Epoetin Alfa for the Treatment of Anemia Due to Revised International Prognostic Scoring System (IPSS-R) Very Low, Low, or Intermediate-Risk Myelodysplastic Syndrome (MDS) in Erythropoiesis-Stimulating Agent (ESA)-Naive Participants Who Are Non-Transfusion Dependent (NTD): The "ELEMENT-MDS" Trial
Volunteers
Health Professionals
What is the purpose of this trial?
The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are non-transfusion dependent (NTD).
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Principal Investigator
Sub-Investigators
- Alain Mina, MD
- Alexis Walker, PA
- Anca Bulgaru, MD
- Armand Russo, MD
- Ashita Talsania, MRCP, MBBS, MD
- Benjamin Newton, MD
- Catherine Wei, MD
- Clarice Grens, APRN
- Daniel Boxer, MD
- Emily Collier, MD
- Francesca Montanari, MD
- Harold Tara Jr, MD
- Jan Philipp Bewersdorf, MD, FACP
- Jason Haldas, MD
- Jean Vollmer, APRN
- Jeremy Kortmansky, MD
- Justin Persico, MD
- Karen Ann Hammond, DNP, APRN, ACNP (BC)
- Karishma Mehra, MBBS
- Katherine Harvey, MD, MPH
- Kathleen Fenn, MD
- Kelly Lavoie, PA
- Kelly Ling, PA
- Kert Sabbath, MD, FACP
- Kristen Hoxie, PA
- Laura Sabourin
- Lisa Barbarotta, APRN
- Lourdes Mendez, MD, PhD
- Luis E. Aguirre, MD, MPH
- Matthew Austin, MD
- Maximilian Stahl, MD
- Michael Cohenuram, MD
- Michael Grant, MD
- Neal Fischbach, MD
- Nicholas Blondin, MD
- Nikolai Podoltsev, MD, PhD
- Pawan Karanam, MD
- Prajwal Boddu, MD, PhD
- Rebecca Vanasse-Passas, MD
- Robert Legare, MD
- Robert Matera, MD
- Rory Shallis, MD
- Sara Anastasio, APRN, RN
- Sarah Thomen, APRN
- Sharynn Hall, MD, PhD
- Stacey LaRosa, APRN
- Stephanie Halene, MD, Dr Med
- Stephen Lattanzi, MD
- Stuart Seropian, MD
- Sudhanshu Mulay, MD
- Syed Ali
- Victor Chang, MD
- Vidya Kesavan
- Yifei Zhang, MD
- Last Updated04/24/2026
- Study IRB#2000035577