OncoMatch/Clinical Trials/NCT05384691
Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions
Is NCT05384691 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Luspatercept for myelodysplastic syndromes.
Treatment: Luspatercept — Anemia in patients with very low, low or intermediate risk myelodysplastic syndromes (MDS), that are non-transfusion dependent
Check if I qualifyExtracted eligibility criteria
Cancer type
Myelodysplastic Syndrome
Disease stage
Required: Stage VERY LOW-RISK, LOW-RISK, INTERMEDIATE-RISK (IPSS-R)
Very low-, low-, or intermediate-risk disease MDS with up to 3.5 according to revised International Prognostic Scoring System (IPSS-R)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: erythropoiesis-stimulating agent (ESA)
Prior treatment for anemia associated with MDS (i.e. ESA, luspatercept), except previously treated with G-CSF/granulocyte-macrophage colony-stimulating factor (GM-CSF), both agents must be discontinued at least 4 weeks before registration
Cannot have received: luspatercept (luspatercept)
Prior treatment for anemia associated with MDS (i.e. ESA, luspatercept), except previously treated with G-CSF/granulocyte-macrophage colony-stimulating factor (GM-CSF), both agents must be discontinued at least 4 weeks before registration
Cannot have received: allogeneic stem cell transplant
Prior allogeneic or autologous stem cell transplant
Cannot have received: autologous stem cell transplant
Prior allogeneic or autologous stem cell transplant
Cannot have received: anticancer cytotoxic chemotherapeutic agent or treatment
Use of any of the following within five weeks prior to registration are prohibited: Anticancer cytotoxic chemotherapeutic agent or treatment
Cannot have received: corticosteroid
Exception: except for subjects on a stable or decreasing dose for ≥ 1 week prior to inclusion for medical conditions other than MDS
Use of any of the following within five weeks prior to registration are prohibited: Corticosteroid, except for subjects on a stable or decreasing dose for ≥ 1 week prior to inclusion for medical conditions other than MDS
Cannot have received: iron chelation therapy
Exception: except for subjects on a stable or decreasing dose for at least 8 weeks prior to registration
Use of any of the following within five weeks prior to registration are prohibited: Iron chelation therapy, except for subjects on a stable or decreasing dose for at least 8 weeks prior to registration
Cannot have received: other RBC hematopoietic growth factors (interleukin [IL]-3)
Use of any of the following within five weeks prior to registration are prohibited: Other RBC hematopoietic growth factors (e.g. interleukin [IL]-3)
Lab requirements
Blood counts
Platelet count < 30,000/μL (30 × 10^9/L) [excluded]
Kidney function
Estimated glomerular filtration rate or creatinine clearance < 40 mL/min [excluded]
Liver function
AST/SGOT ≥ 3.0 × ULN; ALT/SGPT ≥ 3.0 × ULN; Total bilirubin ≥ 2.0 × ULN [excluded]
Cardiac function
Subjects with a known ejection fraction of < 35%, confirmed by echocardiography or MUGA within 6 months prior to registration, are excluded
Platelet count < 30,000/μL (30 × 10^9/L); Estimated glomerular filtration rate or creatinine clearance < 40 mL/min; AST/SGOT ≥ 3.0 × ULN; ALT/SGPT ≥ 3.0 × ULN; Total bilirubin ≥ 2.0 × ULN; Subjects with a known ejection fraction of < 35%, confirmed by a local echocardiography or multigated acquisition scan (MUGA) performed within 6 months prior to registration, are excluded
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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 qualify