NCT05925504

The Tapering Dose of Luspatercept in Patients With Lower-risk Myelodysplastic Syndromes

Safety and Efficacy Study of the Tapering Dose of Luspatercept in Patients With Lower-risk Myelodysplastic Syndromes

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single center, single-arm, phase 2 study. The aim of this study is to evaluate the efficacy and safety of Luspatercept for Patients with Lower-risk Myelodysplastic Syndromes (MDS).

Conditions

• Lower Risk MDS Per IPSS-R

Interventions

Type	Name	Description
DRUG	Luspatercept	The starting dose is 1.75mg/kg once every 3 weeks by subcutaneous injection. For rapid hemoglobin rise after 2 consecutive doses at the 1.75mg/kg starting dose, decrease the dose of Luspatercept or interrupt treatment. Otherwise, continue treatment with the dose of 1.75mg/kg once every 3 weeks.

Timeline

• Start date: 2023-07-01
• Primary completion: 2026-06-30
• Completion: 2026-09-30
• First posted: 2023-06-29
• Last updated: 2024-03-12

Locations

1 site across 1 country: China