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Efficacy and Safety of Maximum Labeled Dose Luspatercept in Lower-Risk Myelodysplastic Syndromes
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
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
Conditions
Interventions
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.