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NOT YET RECRUITING
NCT07894861
PHASE3

Efficacy and Safety of Maximum Labeled Dose Luspatercept in Lower-Risk Myelodysplastic Syndromes

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

Summary

This study is a single-arm, prospective, multi-center, Phase IIIb clinical trial aimed at evaluating the efficacy and safety of the maximum labeled dose of luspatercept in individuals diagnosed with lower-risk myelodysplastic syndromes (MDS). The trial anticipates the enrollment of 75 participants with lower-risk MDS, all of whom will undergo treatment with luspatercept.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2026-10-31

Completion Date

2027-12-31

Last Updated

2026-10-26

Healthy Volunteers

No

Interventions

DRUG

Luspatercept

The patients will undergo a maximum 4-week screening period and then enter the treatment phase, where they will receive subcutaneous injections of luspatercept at 1.75 mg/kg every 3 weeks. If adverse events occur during the treatment, the dosage will be reduced or administration postponed depending on their severity.