OncoMatch/Clinical Trials/NCT05732961

Luspatercept for Anemia in Lower Risk MDS or Non-proliferative MDS/MPN Neoplasms

Is NCT05732961 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Luspatercept for myelodysplastic syndromes.

Phase 2RecruitingH. Lee Moffitt Cancer Center and Research InstituteNCT05732961Data as of May 2026

Treatment: Luspatercept — The purpose of the study is to see if participants with anemia due to their type of MDS or MDS/MPN will experience a more decreased need for regular blood transfusions if they take luspatercept plus best supportive care, and what effect, good and/or bad, luspatercept has on them and their anemia due to MDS or MDS/MPN. The safety and tolerability of luspatercept will also be evaluated in this study.

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Extracted eligibility criteria

Cancer type

Myelodysplastic Syndrome

Myeloproliferative Neoplasm

Biomarker criteria

Required: SF3B1 mutation

Required: SRSF2 mutation

Required: U2AF1 mutation

Required: ZRSR2 mutation

Prior therapy

Must have received: hypomethylating agent

Cohort 2: SF3B1 mutation with prior treatment with hypomethylating agent and or lenalidomide

Must have received: (lenalidomide)

Cohort 2: SF3B1 mutation with prior treatment with hypomethylating agent and or lenalidomide

Must have received: erythropoiesis-stimulating agent (rHu EPO, darbepoetin alpha)

Refractory, intolerant to, or ineligible for, prior ESA treatment

Cannot have received: stem cell transplant

Prior allogeneic or autologous stem cell transplant

Cannot have received: (Luspatercept, Sotatercept)

Prior treatment with Luspatercept or Sotatercept

Lab requirements

Blood counts

ANC ≥ 500/μL; Platelet count ≥ 50,000/μL

Kidney function

eGFR ≥ 30 mL/min/1.73 m2

Liver function

ALT or AST < 3 × ULN

ANC < 500/μL (0.5 x 10^9/L); Platelet count <50,000/μL (50 x 10^9/L); Severe renal impairment (eGFR < 30 mL/min/1.73 m2); ALT or AST ≥ 3 × ULN

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

Moffitt Cancer Center · Tampa, Florida

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