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NCT07894861
Efficacy and Safety of Maximum Labeled Dose Luspatercept in Lower-Risk Myelodysplastic Syndromes
Conditions: Myelodysplastic Syndromes
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 75
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.
Eligibility Criteria
Inclusion Criteria:
* Age ≥18 years;
* Diagnosed with myelodysplastic syndrome with an IPSS-R score ≤3.5;
* Requires at least 2 units of red blood cell transfusions within the 8 weeks prior to treatment;
* ECOG performance status ≤2;
* Willing and able to comply with the requirements for this study and written informed consent.
Exclusion Criteria:
* Platelet count \
Source: ClinicalTrials.gov (NCT07894861). StuddyBuddy aggregates publicly available trial information.
