A phase II, open-label, single arm study to evaluate the efficacy ofLuspatercept in Erythropoiesis-stimulating agent naive lower-riskMDS patients with or without ring sideroblasts who do not requireRBC transfusions
Phase 1
- Conditions
- Patients with very low, low or intermediate risk myelodysplastic syndromes (MDS) presenting with anemia, transfusionindependence (NTD) and naive towards ESA treatmentTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2024-516438-36-00
- Lead Sponsor
- niversitaet Leipzig
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Diagnosis of MDS according to WHO classification, Very low-, low-, or intermediate-risk disease with up to 3.5 score points according to revised International Prognostic Scoring System (IPSS-R) classification, Non-transfusion dependence (NTD) according to IWG 2018, Symptomatic anemia: mean baseline Hb < 10 g/d
Exclusion Criteria
Secondary MDS, Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding, Prior allogeneic or autologous stem cell transplant, ECOG > 2, Prior ESA treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method