A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) (NCT04419649)

🧪 Interventions in This Study

• Elritercept (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. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local study participant privacy regulations.
2. Male or female ≥ 18 years of age, at the time of signing informed consent.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia).
4. Females of childbearing potential and sexually active males must agree to use highly effective methods of contraception.
5. In the opinion of the Investigator, the participant is able and willing to comply with the requirements of the protocol (e.g., all study procedures, return for follow-up visits). Part 1 Inclusion Criteria Participants are eligible to be included in Part 1 of the study only if all the following criteria apply:
6. Diagnosis of MDS according to WHO classification that meets International Prognostic Scoring System-Revised (IPSS-R) classification of very low, low, or intermediate risk disease.
7. Less than (\<)5percent (%) blasts in bone marrow during the Pretreatment Period.
8. Peripheral blood white blood cell (WBC) count \<13,000/microliter (μL) during the Pretreatment Period.
9. Anemia defined as:
10. In non-transfused participants, having received no RBC transfusions within 8 weeks, Hgb concentration ≤ 10.0 g/dL during the Pretreatment Period OR
11. In LTB participants, having received 1 to 3 units of RBCs for Hgb ≤ 9.0 g/dL within 8 weeks of the Pretreatment Period. OR
12. In HTB participants, having received ≥ 4 units of RBCs for Hgb ≤ 9.0 g/dL within 8 weeks of the Pretreatment Period. Part 1 Extension - Abbreviated Inclusion Criteria Participants from Part 1 are eligible to be included in Part 1 Extension of the study only if all the following criteria apply:

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

📍 All Participating Trial Locations (53 Sites)

Showing the first 25 of 53 sites.

• Genesis Cancer and Blood Institute — Hot Springs, Arkansas
• City of Hope National Medical Center — Duarte, California
• University of Miami School of Medicine Sylvester Comprehensive Cancer Center (SCCC) — Miami, Florida
• H. Lee Moffitt Cancer Center and Research Center — Tampa, Florida
• The Center for Cancer and Blood Disorders (CCBD) - Bethesda — Bethesda, Maryland
• Karmanos Cancer Institute at Mclaren Greater Lansing — Lansing, Michigan
• Hackensack Medical Center — Hackensack, New Jersey
• New York Cancer and Blood — Shirley, New York
• University of Pittsburgh Medical Health Center — Pittsburgh, Pennsylvania
• Baptist Clinical Research Institute — Memphis, Tennessee
• Univ of Texas MD Anderson Cancer Center, Division of Cancer Medicine — Houston, Texas
• Border Medical Oncology Research — Albury, New South Wales
• Tweed Hospital — Tweed Heads, New South Wales
• Westmead Hospital — Westmead, New South Wales
• Townsville University Hospital — Douglas, Queensland
• Royal Adelaide Hospital — Adelaide, South Australia
• Flinders Medical Centre — Bedford Park, South Australia
• Boxhill Hospital — Box Hill, Victoria
• University Hospital Geelong — Geelong, Victoria
• Austin Health — Heidelberg, Victoria
• Royal Melbourne Hospital — Melbourne, Victoria
• St Vincent's Hospital Melbourne — Melbourne, Victoria
• Ballarat Oncology & Haematology Service — Wendouree, Victoria
• Fakultni nemocnice Brno — Brno,
• Fakultni nemocnice Kralovske Vinohrady — Prague,

📞 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 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
• Ascorbate in Myelodysplastic Syndrome — Iowa City, Iowa
• A Study of Tebapivat (AG-946) in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes (LR-MDS) — Lakewood, California
• Leflunomide in Combination With Decitabine for Treatment of Relapsed or Refractory Myelodysplastic Syndromes — Morgantown, West Virginia

Explore by condition: All Myelodysplastic Syndromes 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.