OncoMatch/Clinical Trials/NCT07422480
A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Lower Risk Myelodysplastic Syndromes (LR-MDS) Who Need Regular Blood Transfusions
Official title: A Phase 3, Multicenter, Open-Label, Randomized Trial to Compare the Efficacy and Safety of Elritercept Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in ESA-naïve Adult Participants Who Require Red Blood Cell Transfusions
Is NCT07422480 recruiting? Yes, currently enrolling (Oct 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 much elritercept reduces the need for RBC (red blood cell) transfusions and improves hemoglobin blood values in addition to how safe elritercept is when compared with epoetin alfa. Other key aims are to learn how much elritercept improves tiredness and quality of life as reported by participants compared with epoetin alfa; to assess what risks (side effects) and how often they occur with elritercept compared with epoetin alfa. The study will also collect information for researchers to see how the disease in the bone marrow or other body areas may be affected by elritercept compared with epoetin alfa to try to learn how to better treat this disease.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Myelodysplastic Syndrome
Biomarker criteria
Required: EPO expression (<500 U/L)
Endogenous serum erythropoietin (EPO) level of <500 units per liter (U/L)
Required: TP53 wild-type
Bone marrow less than (<) 5% blasts in an evaluable bone marrow collected at screening and confirmed by central pathology independent reviewer.
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: luspatercept, sotatercept, imetelstat, or elritercept (luspatercept, sotatercept, imetelstat, elritercept)
Luspatercept, sotatercept, imetelstat, or elritercept
Cannot have received: immunosuppressive therapy for the disease under study
Immunosuppressive therapy for the disease under study
Cannot have received: hematopoietic cell transplant
Hematopoeitic cell transplant
Cannot have received: investigational agent or any other agent intended for MDS treatment
Investigational agent or any other agent intended for MDS treatment
Lab requirements
Blood counts
ANC <500/μL; Platelet count <50,000/μL or ≥800,000/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
Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3× upper limit of the normal (ULN); Total bilirubin ≥2×ULN (exceptions for Gilbert syndrome and ineffective erythropoiesis)
Cardiac function
Known ejection fraction <35% by echocardiogram; NYHA class III or IV; QTcF >500 ms; uncontrolled arrhythmia, MI, or unstable angina within 6 months
See exclusion criteria 5, 6, 18 for full details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial 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
- Yale · New Haven, Connecticut
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07422480 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior luspatercept, sotatercept, imetelstat, or elritercept, immunosuppressive therapy for the disease under study, hematopoietic cell transplant disqualifies patients from enrollment.
Does this trial require EPO?
Yes, EPO expression is a required biomarker for enrollment.
Does this trial require TP53?
Yes, TP53 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage VERY LOW-RISK or LOW-RISK or INTERMEDIATE-RISK is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages