NCT05732961

Luspatercept for Anemia in Lower Risk MDS or Non-proliferative MDS/MPN Neoplasms

A Phase 2, Single Arm Study of Luspatercept for the Treatment of Anemia in Lower Risk Myelodysplastic Syndromes (MDS) or Non-Proliferative Myelodysplastic Syndromes/ Myeloproliferative Neoplasms (MDS/MPN)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to see if participants with anemia due to their type of MDS or MDS/MPN will experience a more decreased need for regular blood transfusions if they take luspatercept plus best supportive care, and what effect, good and/or bad, luspatercept has on them and their anemia due to MDS or MDS/MPN. The safety and tolerability of luspatercept will also be evaluated in this study.

Conditions

• Myelodysplastic Syndromes
• Myeloproliferative Neoplasm
• Anemia

Interventions

Type	Name	Description
DRUG	Luspatercept	Participants will be treated with Luspatercept, with a starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (administered on Day 1 of each 21-day treatment cycle)

Timeline

• Start date: 2023-02-21
• Primary completion: 2026-06-20
• Completion: 2026-09-01
• First posted: 2023-02-17
• Last updated: 2025-12-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study