At a glance
ClinicalIndex Comparison Record- ✓Documented MDS diagnosis per WHO 2016 with IPSS-R very low, low, or intermediate risk and <5% bone marrow blasts
- ✓Serum erythropoietin (sEPO) level <500 U/L
- ✓Average RBC transfusion requirement of 2-6 units per 8 weeks for minimum 8 weeks before randomization
- ✓ECOG performance status 0, 1, or 2
- ✕Clinically significant anemia from iron, B12, folate deficiency, autoimmune/hereditary hemolytic anemia, hypothyroidism, or clinically significant bleeding/sequestration/drug-induced anemia
- ✕History of AML diagnosis
- ✕Uncontrolled hypertension (repeated SBP ≥150 mmHg and/or DBP ≥100 mmHg despite treatment)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alpha for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) in ESA Naïve Subjects Who Require Red Blood Cell Transfusions
In Brief
A Phase 3 clinical trial evaluating Luspatercept and Epoetin alfa for Myelodysplastic Syndromes. Active but no longer recruiting, targeting 363 participants across 226 sites in 26 countries.
Detailed Summary
The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dL in participants with anemia due to revised international prognostic scoring system (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require RBC transfusions and have never been exposed to erythropoiesis stimulating agent (ESA).
Study Details
Timeline
Interventions
Specified dose on specified days
Specified dose on specified days