OncoMatch/Clinical Trials/NCT07096297
Luspatercept + Darbepoetin in MDS
Is NCT07096297 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Luspatercept and Darbeopoetin for mds (myelodysplastic syndrome).
Treatment: Luspatercept · Darbeopoetin — This is a single arm open-label Phase II trial of luspatercept and darbepoetin alfa in non-mutated SF3B1 , lower-risk, RBC transfusion dependent MDS participants with an endogenous erythropoietin (EPO) level \< 500 IU/L.
Check if I qualifyExtracted eligibility criteria
Cancer type
Myelodysplastic Syndrome
Biomarker criteria
Required: SF3B1 mutation
Absence of SF3B1 mutation
Required: EGR1 deletion of 5q
Absence of del5q
Disease stage
Required: Stage VERY LOW, LOW, INTERMEDIATE (IPSS-R)
very low, low and intermediate risk by International Prognostic Scoring System-Revised (IPSS-R) criteria
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Cannot have received: erythropoiesis-stimulating agent (epoetin alfa, darbepoetin alfa)
Exception: ≤ 2 doses of prior epoetin alfa or ≤ 1 dose darbepoetin alfa if ≥ 8 weeks from date of consent
Prior treatment with ESA, luspatercept, hypomethylating agents or lenalidomide/thalidomide/other immunomodulating drug (IMiDs). Exception 1: Participants can have received ≤ 2 doses of prior epoetin alfa or ≤ 1 dose darbepoetin alfa if ≥ 8 weeks from date of consent.
Cannot have received: luspatercept (luspatercept)
Prior treatment with ESA, luspatercept, hypomethylating agents or lenalidomide/thalidomide/other immunomodulating drug (IMiDs).
Cannot have received: hypomethylating agent (azacitidine, decitabine)
Prior treatment with ESA, luspatercept, hypomethylating agents or lenalidomide/thalidomide/other immunomodulating drug (IMiDs).
Cannot have received: immunomodulating drug (lenalidomide, thalidomide)
Exception: ≤ 1 week of treatment with lenalidomide ≥ 8 weeks from the date of consent, at the sponsor-investigator's discretion
Prior treatment with ESA, luspatercept, hypomethylating agents or lenalidomide/thalidomide/other immunomodulating drug (IMiDs). Exception 2: Participants can have received ≤ 1 week of treatment with lenalidomide ≥ 8 weeks from the date of consent, at the sponsor-investigator's discretion.
Lab requirements
Kidney function
Creatinine clearance > 30 mL/min based on the Cockroft-Gault glomerular filtration rate (GFR) estimation
Liver function
AST/SGOT and ALT/SGPT ≤ 3 x ULN, unless considered due to organ involvement by the participant's myeloid malignancy (in that case a cut off ≤ 5 x ULN will be used); Serum direct bilirubin < 1.5 x ULN
Participant has adequate organ function defined as: AST/SGOT and ALT/SGPT ≤ 3 x ULN, unless considered due to organ involvement by the participant's myeloid malignancy (in that case a cut off ≤ 5 x ULN will be used); Serum direct bilirubin < 1.5 x ULN; Creatinine clearance > 30 mL/min based on the Cockroft-Gault glomerular filtration rate (GFR) estimation.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Yale University · New Haven, Connecticut
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University · Chicago, Illinois
- Harold C. Simmons Comprehensive Cancer Center of UT Southwestern · Dallas, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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