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OncoMatch/Clinical Trials/NCT07422480

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

Is NCT07422480 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Elritercept and Epoetin Alfa for myelodysplastic syndrome.

Phase 3RecruitingTakedaNCT07422480Data as of May 2026

Treatment: Elritercept · Epoetin AlfaThe main aim of this study is to assess how elritercept works in lowering the need for RBC (red blood cell) transfusions and how safe elritercept is when compared with epoetin alfa. Other aims are to learn if elritercept improves tiredness as reported by participants without needing RBC transfusion compared with epoetin alfa, the RBC transfusion burden and quality of life compared with epoetin alfa. The study also aims to find out the extent of the immune response to elritercept. The study will also check on the medical problems (safety) of elritercept.

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Extracted eligibility criteria

Cancer type

Myelodysplastic Syndrome

Disease stage

Required: Stage VERY LOW-RISK, LOW-RISK, INTERMEDIATE-RISK (IPSS-R)

Excluded: Stage SECONDARY MDS

IPSS-R classification of very low-, low-, or intermediate-risk disease

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: epoetin alfa (epoetin alfa)

Exception: may be allowed if received no more than 2 doses of only epoetin alfa ≥8 weeks prior to randomization

Prior therapy with epoetin alfa

Cannot have received: erythropoiesis-stimulating agent

Exception: No other ESA agent is allowed

No other erythropoiesis-stimulating agent (ESA) agent is allowed

Cannot have received: darbepoetin (darbepoetin)

Prior therapy with darbepoetin

Cannot have received: granulocyte colony-stimulating factor (granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor)

Exception: unless given for treatment of febrile neutropenia

Granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor administered ≤8 weeks (56 days) prior to randomization unless given for treatment of febrile neutropenia

Cannot have received: immunomodulatory drug (lenalidomide)

Exception: may be allowed if received ≤1 week of an IMiD ≥8 weeks prior to randomization

Immunomodulatory drug (IMiDs) including lenalidomide

Cannot have received: hypomethylating agent

Exception: may be allowed if received no more than 2 doses ≥8 weeks prior to randomization

Hypomethylating agent

Cannot have received: luspatercept, sotatercept, imetelstat, or elritercept (luspatercept, sotatercept, imetelstat, elritercept)

Luspatercept, sotatercept, imetelstat, or elritercept

Cannot have received: immunosuppressive therapy

Immunosuppressive therapy

Cannot have received: hematopoietic cell transplant

Hematopoeitic cell transplant

Cannot have received: iron chelation

Exception: Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed

Iron chelation if administered ≤8 weeks prior to randomization

Cannot have received: vitamin B12 or folate therapy

Exception: Participants on stable replacement doses for ≥4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed

Vitamin B12 or folate therapy initiated within 4 weeks prior to randomization

Cannot have received: androgen

Exception: Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed

Androgen use within 8 weeks before randomization

Cannot have received: high-dose corticosteroid

Exception: Participants on stable chronic steroid doses of prednisone ≤10 mg/day or corticosteroid equivalent for ≥ 4 weeks are allowed

High-dose corticosteroid use within 4 weeks before randomization

Cannot have received: investigational agent

Investigational agent or any other agent intended for treatment MDS treatment

Lab requirements

Blood counts

ANC ≥500/μL; platelet count ≥50,000/μL and <450,000/μL; ferritin >50 μg/L; folate >2.0 ng/mL; vitamin B12 >200 pg/mL

Kidney function

Estimated glomerular filtration rate ≥30 mL/min/1.73 m^2 (CKD-EPI equation)

Liver function

AST or ALT <3× ULN; total bilirubin <2× ULN (exceptions for Gilbert syndrome and ineffective erythropoiesis)

Cardiac function

Ejection fraction ≥35%; no NYHA class III/IV heart disease; QTcF ≤500 ms; no uncontrolled arrhythmia, MI, or unstable angina within 6 months

ANC <500/μL, platelet count <50,000/μL or ≥450,000/μL, AST or ALT ≥3× ULN, total bilirubin ≥2× ULN, eGFR <30 mL/min/1.73 m^2, ferritin ≤50 μg/L, folate ≤2.0 ng/mL, vitamin B12 ≤200 pg/mL, ejection fraction <35%, NYHA class III/IV, QTcF >500 ms, uncontrolled arrhythmia, MI, or unstable angina within 6 months

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Hematology-Oncology Medical Group of Orange County, Inc - Orange - 1010 W. La Veta Avenue · Orange, California
  • BRCR Medical Center Inc · Tamarac, Florida
  • Emory University · Atlanta, Georgia
  • Orchard Healthcare Research Inc. (OHR) - Skokie · Skokie, Illinois
  • Norton Cancer Institute · Louisville, Kentucky

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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