NCT07096297

Luspatercept + Darbepoetin in MDS

A Phase II Study of Luspatercept Plus Darbepoetin Alfa in Non-mutated SF3B1 Lower-risk Myelodysplastic Syndromes

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. Each participant will be treated with luspatercept in combination with darbepoetin alfa every 21 days (three weeks). Both agents will be administered on day 1 of each 21-day (three weeks) cycle. Based on the individual participant's response to combination therapy of luspatercept and darbepoetin alfa, the doses of luspatercept and/or darbepoetin alfa can be either decreased or increased.

Conditions

• MDS (Myelodysplastic Syndrome)

Interventions

Type	Name	Description
DRUG	Luspatercept	Luspatercept will be administered every 3 weeks (21 days) at a starting dose of 1.0 mg/kg (Dose Level 0). Luspatercept will be administered to participants by the study staff at the clinical site and administration will be documented in the participant's source record. Participants must have Hgb, blood pressure and weight assessed (changes of body weight of ≤ ± 5% do not require a dose adjustment) prior to each luspatercept dose administration. Subcutaneous injections will be given in the upper arm, thigh, and/or abdomen. Volume for subcutaneous injection will be per institutional standard/guidelines.
DRUG	Darbeopoetin	Darbepoetin alfa will be administered every 3 weeks (21 days), at a starting dose of 300 ug (Dose Level 0). Darbepoetin alfa will be administered to participants by the study staff at the clinical site and administration will be documented in the participant's source record. Darbepoetin alfa will be administered as a subcutaneous injection by the site staff in the upper arm, thigh, and/or abdomen per institutional standard/guidelines.

Timeline

• Start date: 2025-12-16
• Primary completion: 2030-08-01
• Completion: 2030-08-01
• First posted: 2025-07-31
• Last updated: 2026-03-23

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study