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.
Treatment: Elritercept · Epoetin Alfa — The 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.
Check if I qualifyExtracted 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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