Clinical Trial

Luspatercept + Darbepoetin in MDS

Study acronym: DarbeLus
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
This is a single arm open-label Phase II trial of luspatercept and darbepoetin alfa in non-mutated SF3B1 , lower-risk, RBC transfusion dependent MDS participants with an endogenous erythropoietin (EPO) level \< 500 IU/L.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2025-07-23; most recent amendment 2026-03-20.
Status change: Not Yet Recruiting → Recruiting 2025-12-12
Trial Details
NCT Number NCT07096297
Lead Sponsor Yale University
Collaborators: Bristol-Myers Squibb
Conditions MDS (Myelodysplastic Syndrome)
Enrollment 60 participants
Start Date 2025-12-16
Primary Completion 2030-08 (estimated)
Study Completion 2030-08 (estimated)
Updated on ClinicalTrials.gov 2026-03-23