NCT06113302

A Pilot, Open-Label Study of Luspatercept for Patients With Lower Risk Myelodysplastic Syndromes (MDS)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if luspatercept is more effective in helping to reduce the number of blood transfusions needed by patients with LR-MDS.

Detailed description

Objectives: Primary Objectives: * To assess the clinical activity and safety of luspatercept in patients with transfusion independent lower risk MDS * To assess the clinical activity and safety of luspatercept in patients with transfusion dependent lower risk MDS * To study the effects on hematopoeisis of luspatercept in patients treated on this study Secondary Objectives: * To assess the duration of response of patients with treated with luspatercept in this study * To assess the overall survival and time to transformation of patients with treated with luspatercept in this study * To assess transfusion free survival period in patients that were transfusion independent treated with luspatercept in this study * To measure trends in neutrophil and platelet counts in patients treated in this study

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Luspatercept	Given by SC or (Injection)

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-06-02
• Completion: 2026-06-02
• First posted: 2023-11-02
• Last updated: 2025-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study