A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions (NCT07422480)

🧪 Interventions in This Study

• Elritercept (DRUG)
• Epoetin Alfa (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Male or female participants aged ≥ 18 years or older at time of signing the informed consent form (ICF).
2. Able to understand the purpose and risks of the trial and voluntarily sign an ICF prior to any trial-related procedures being conducted and authorization to use protected health information and personal data in accordance to national and local privacy regulations.
3. Documented diagnosis of myelodysplastic syndrome(s) (MDS) according to WHO 2016 classification that meets International Prognostic Scoring System - Revised (IPSS-R) classification of very low-, low-, or intermediate-risk disease, confirmed by central laboratory independent reviewer prior to randomization. Hemoglobin (Hgb), platelet, and absolute neutrophil count (ANC) values should be collected greater than (\>) 14 days after red blood cell (RBC) transfusion or greater than (\>) 7 days after platelet transfusion, unless otherwise considered to be pretransfusion values.
4. Bone marrow less than (\<) 5% blasts in an evaluable bone marrow collected at screening and confirmed by central pathology independent reviewer.
5. Endogenous serum erythropoietin s (EPO) level of \<500 U/L. Should be results from blood samples collected \>14 days following an RBC transfusion to evaluate for eligibility unless considered pretransfusion values.
6. Participant requires RBC transfusion, as documented by the following criteria. A transfusion requirement of 2 to 6 pRBCs units/8 weeks confirmed for a minimum of 8 weeks immediately preceding randomization.
7. Hgb levels at the time of or within 3 days prior to administration of a RBC transfusion must have been less than or equal to (≤) 9.0 grams per deciliter (g/dL) (5.6 millimoles per liter (mmol/L)) with symptoms of anemia (or ≤7 g/dL \[4.3 mmol/L\] in the absence of symptoms) in order for the transfusion to be counted towards meeting eligibility criteria.
8. RBC transfusions administered when hemoglobin (Hgb) levels were \>9.0 g/dL (or \>7 g/dL in the absence of symptoms) and/or RBC transfusions administered for elective surgery, infections or bleeding events will not qualify as a required transfusion for the purpose of meeting eligibility criteria or stratification.
9. Hgb \<11.0 g/dL (6.8 mmol/L) after last RBC transfusion preceding randomization. Local laboratory is acceptable to facilitate randomization.
10. Eastern Cooperative Oncology Group score of 0, 1, or 2. Exclusion Criteria <!-- -->
11. Prior therapy with any of the following:
12. Epoetin alfa

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (156 Sites)

Showing the first 25 of 156 sites.

• Banner MD Anderson Cancer Center — Gilbert, Arizona
• City of Hope - Comprehensive Cancer Center (CCC) — Duarte, California
• Providence Medical Group — Santa Rosa, California
• Cancer & Blood Research Center — Whittier, California
• University of Miami — Miami, Florida
• BRCR Medical Center Inc — Tamarac, Florida
• Moffitt Cancer Center — Tampa, Florida
• Emory University — Atlanta, Georgia
• Orchard Healthcare Research Inc. (OHR) - Skokie — Skokie, Illinois
• Norton Cancer Institute — Louisville, Kentucky
• American Oncology Partners P.A. MidAmerica Cancer Care — Kansas City, Missouri
• Albert Einstein College - Montefiore — The Bronx, New York
• Novant Health Care Institute — Winston-Salem, North Carolina
• Cleveland clinic OH — Cleveland, Ohio
• Fox Chase Cancer Center — Philadelphia, Pennsylvania
• Tennessee Oncology, PLLC — Nashville, Tennessee
• World Research Link — Baytown, Texas
• Texas Oncology - Denton — Denton, Texas
• The Center for Cancer and Blood Disorders — Fort Worth, Texas
• The University of Texas-MD Anderson Cancer Center - Leukemia Center — Houston, Texas
• LUMI Research — Houston, Texas
• Renovatio Clinical — The Woodlands, Texas
• Huntsman Cancer Institute — Salt Lake City, Utah
• Virginia Commonwealth University (VCU)-Medical Center - North Hospital — Richmond, Virginia
• West Virginia University Cancer Institute — Wheeling, West Virginia

📞 Contact the Study Coordinator

Phone: (877) 825-3327

Email: medinfoUS@takeda.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 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 Syndrome

• A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies — Birmingham, Alabama
• Revisiting the Universal Donor: Does Exposure to O Blood Products Affect Patient Outcomes? — Hamilton, Ontario
• Study of a Geriatric Assessment to Plan a Treatment Approach for Older People With Various Blood Disorders — Basking Ridge, New Jersey
• A Phase Ib Study of Rezatapopt in Combination With Azacitidine in Patients With TP53Y220C Mutant Myeloid Malignancies (Acute Myeloid Leukemia or Myelodysplastic Syndrome) — Tampa, Florida
• Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myelodysplastic Syndrome (MDS) With IDH2 Mutation (A MyeloMATCH Treatment Trial) — Berkeley, California

Explore by condition: All Myelodysplastic Syndrome clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
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.