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NCT07422480
A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Lower Risk Myelodysplastic Syndromes (LR-MDS) Who Need Regular Blood Transfusions
Conditions: Myelodysplastic Syndrome, Anemia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 300
Sponsor: Takeda
Location: Banner MD Anderson Cancer Center Gilbert Arizona
Summary
The main aim of this study is to assess how much elritercept reduces the need for RBC (red blood cell) transfusions and improves hemoglobin blood values in addition to how safe elritercept is when compared with epoetin alfa. Other key aims are to learn how much elritercept improves tiredness and quality of life as reported by participants compared with epoetin alfa; to assess what risks (side effects) and how often they occur with elritercept compared with epoetin alfa. The study will also collect information for researchers to see how the disease in the bone marrow or other body areas may be affected by elritercept compared with epoetin alfa to try to learn how to better treat this disease.
Eligibility Criteria
Inclusion Criteria
1. Male or female participants aged ≥ 18 years or older at time of signing the informed consent form (ICF).
2. Able to understand the purpose and risks of the trial and voluntarily sign an ICF prior to any trial-related procedures being conducted and authorization to use protected health information and personal data in accordance to national and local privacy regulations.
3. Documented diagnosis of myelodysplastic syndrome(s) (MDS) according to WHO 2016 classification that meets International Prognostic Scoring System - Revised (IPSS-R) classification of very low-, low-, or intermediate-risk disease, confirmed by central laboratory independent reviewer prior to randomization. Hemoglobin (HgB), platelet, and absolute neutrophil count (ANC) values should be collected greater than (\>) 14 days after red blood cell (RBC) transfusion or \> 7 days after platelet transfusion, unless otherwise considered to be pretransfusion values.
4. Bone marrow less than (\9.0 g/dL (or \>7 g/dL in the absence of symptoms) and/or RBC transfusions administered for elective surgery, infections or bleeding events will not qualify as a required transfusion for the purpose of meeting eligibility criteria or stratification.
7. Hgb \500 milliseconds during screening
3. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening
6. Known ejection fraction \
Source: ClinicalTrials.gov (NCT07422480). StuddyBuddy aggregates publicly available trial information.