OncoMatch/Clinical Trials/NCT06499285
A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions
Is NCT06499285 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Elritercept for myelodysplastic syndromes.
Treatment: Elritercept — The main aim of this study is to find out how well elritercept works in lowering the need for RBC transfusions. Other aims are to learn how well elritercept works in reducing the need for RBC transfusions over longer periods of time or in adults with high transfusion needs. The study will also check on how safe elritercept is and how well it is tolerated.
Check if I qualifyExtracted eligibility criteria
Cancer type
Myelodysplastic Syndrome
Disease stage
Required: Stage VERY LOW, LOW, INTERMEDIATE (IPSS-R)
IPSS-R classification of very low, low, or intermediate risk disease
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: erythropoiesis-stimulating agent (recombinant human erythropoietin, darbepoetin alpha)
Refractory or intolerant to prior erythropoiesis-stimulating agent (ESA) treatment (discontinued ≥4 weeks before randomization), or unlikely to respond to ESA treatment
Cannot have received: elritercept (elritercept)
Prior use of elritercept
Cannot have received: luspatercept (luspatercept)
Prior use of luspatercept
Cannot have received: sotatercept (sotatercept)
Prior use of sotatercept
Cannot have received: hypomethylating agent
Prior use of hypomethylating agents (HMAs)
Cannot have received: isocitrate dehydrogenase inhibitor
Prior use of isocitrate dehydrogenase inhibitor
Cannot have received: immunomodulatory drug (lenalidomide)
Prior use of lenalidomide
Cannot have received: telomerase inhibitor (imetelstat)
Prior use of imetelstat
Cannot have received: immunosuppressive therapy
Prior use of immunosuppressive therapy given for treatment of MDS
Lab requirements
Blood counts
Platelet count ≥450 × 10^9/L or ≤25 × 10^9/L; Absolute neutrophil count ≤ 500/µL; Ferritin ≤ 50 μg/L; Folate ≤2.0 ng/mL; Vitamin B12 ≤200 pg/mL; Less than 5% blasts in bone marrow
Kidney function
Estimated glomerular filtration rate <30 mL/min/1.73m^2 (CKD-EPI equation)
Liver function
Child-Pugh class C hepatic impairment [excluded]; Serum aspartate aminotransferase or alanine aminotransferase ≥3 × ULN; Total bilirubin ≥2 × ULN unless attributable to Gilbert's syndrome
Cardiac function
NYHA class III or IV; QTcF >500 ms; uncontrolled hypertension (SBP ≥160 mm Hg or DBP ≥100 mm Hg); uncontrolled arrhythmia, MI, or unstable angina within 6 months; known ejection fraction <35%
Clinically significant cardiovascular disease defined as: NYHA class III or IV; QTcF >500 ms; uncontrolled hypertension (SBP ≥160 mm Hg or DBP ≥100 mm Hg); uncontrolled arrhythmia, MI, or unstable angina within 6 months; known ejection fraction <35%; Serum aspartate aminotransferase or alanine aminotransferase ≥3 × ULN; Total bilirubin ≥2 × ULN unless attributable to Gilbert's syndrome; Estimated glomerular filtration rate <30 mL/min/1.73m^2 (CKD-EPI equation); Platelet count ≥450 × 10^9/L or ≤25 × 10^9/L; Absolute neutrophil count ≤ 500/µL; Ferritin ≤ 50 μg/L; Folate ≤2.0 ng/mL; Vitamin B12 ≤200 pg/mL; Less than 5% blasts in bone marrow
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope · Duarte, California
- Los Angeles Cancer Network · Glendale, California
- UC San Diego Moores Cancer Center · La Jolla, California
- Smilow Cancer Hospital at Yale-New Haven · New Haven, Connecticut
- University of Miami Hospital and Clinics · Miami, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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