Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Leipzig
About this trial
Anemia in patients with very low, low or intermediate risk myelodysplastic syndromes (MDS), that are non-transfusion dependent
Eligibility criteria
Qualifiers
Diagnosis of myelodysplastic syndrome (MDS) according to WHO classification
Very low-, low-, or intermediate-risk disease MDS with up to 3.5 according to revised International Prognostic Scoring System (IPSS-R)
Less than 5% blasts in bone marrow
Peripheral blood white blood cell (WBC) count < 13,000/μL
Disqualifiers
Patient does not accept bone marrow sampling during screening and during treatment
Patient does not accept regular peripheral blood sampling for screening and during treatment.
Patient does not accept subcutaneous application of LUS every three weeks
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
Trial design
Treatments tested in this trial
- Luspatercept Injection
Treatment groups
213 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Leipzig
Lead sponsor
Celgene Corporation
Collaborator
Source ClinicalTrials.gov