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 (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT05384691 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage VERY LOW-RISK or LOW-RISK or INTERMEDIATE-RISK 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