OncoMatch/Clinical Trials/NCT07096297
Luspatercept + Darbepoetin in MDS
Is NCT07096297 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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 →Frequently asked questions
Is NCT07096297 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior erythropoiesis-stimulating agent, luspatercept, hypomethylating agent disqualifies patients from enrollment.
Does this trial require SF3B1?
Yes, SF3B1 mutation is a required biomarker for enrollment.
Does this trial require EGR1?
Yes, EGR1 deletion of 5q is a required biomarker for enrollment.
What disease stage is eligible?
Stage VERY LOW or LOW or INTERMEDIATE is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages