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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

RecruitingPhase 3Ages 18 Years - anyAllTakeda
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 (\<) 5% blasts in an evaluable bone marrow collected at screening and confirmed by central pathology independent reviewer. 5. Endogenous serum erythropoietin (EPO) level of \<500 units per liter (U/L). Should be results from blood samples collected \>14 days following an RBC transfusion to evaluate for eligibility unless considered pretransfusion values. 6. Participant requires RBC transfusion, as documented by the following criteria. A transfusion requirement of 2 to 6 pRBCs units/8 weeks confirmed for a minimum of 8 weeks immediately preceding randomization. * Hgb levels at the time of or within 3 days prior to administration of a RBC transfusion must have been less than or equal to (≤) 9.0 grams per deciliter (g/dL) (5.6 millimoles per liter (mmol/L)) with symptoms of anemia (or ≤7 g/dL \[4.3 mmol/L\] in the absence of symptoms) in order for the transfusion to be counted towards meeting eligibility criteria. * RBC transfusions administered when hemoglobin (Hgb) levels were \>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 \<11.0 g/dL (6.8 mmol/L) before randomization. Local laboratory is acceptable to facilitate randomization. 8. Eastern Cooperative Oncology Group score of 0, 1, or 2. Exclusion Criteria 1. Prior therapy with any of the following: 1. Epoetin alfa • At the investigator's discretion in consultation with the medical monitor, may be allowed if received no more than 2 doses of only epoetin alfa ≥8 weeks prior to randomization. 2. Darbepoetin • At the investigator's discretion in consultation with the medical monitor, may be allowed if received no more than 1 dose of only darbepoetin ≥8 weeks prior to randomization. 3. Granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor administered ≤8 weeks (56 days) prior to randomization unless given for treatment of febrile neutropenia. 4. Immunomodulatory drug (IMiDs) including lenalidomide • At the investigator's discretion in consultation with the medical monitor may be allowed if received ≤1 week of an IMiD ≥8 weeks prior to randomization. 5. Hypomethylating agent • At the investigator's discretion, in consultation with the medical monitor may be allowed if received no more than 2 doses ≥8 weeks prior to randomization. 6. Luspatercept, sotatercept, imetelstat, or elritercept 7. Immunosuppressive therapy for the disease under study. 8. Hematopoeitic cell transplant 9. Iron chelation if initiated ≤8 weeks prior to randomization. Participants on stable or decreasing doses of iron chelation therapy for ≥8 weeks are allowed. 10. Vitamin B12 or folate therapy initiated within 4 weeks prior to randomization. Participants on stable or decreasing replacement doses for ≥4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed. 11. Androgen use within 8 weeks before randomization. Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed 12. High-dose systemic corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone ≤10 millligrams per day (mg/day) or corticosteroid equivalent for ≥4 weeks are allowed. Other disease modifying treatments for autoimmune diseases may be allowed upon medical monitor review. 13. Investigational agent or any other agent intended for MDS treatment 2. Diagnosed to have MDS with presence of del(5q) cytogenetic abnormality or MDS unclassifiable according to WHO 2016 classification or secondary MDS. 3. Known history of diagnosis of acute myeloid leukemia (AML). 4. Anemia due to any other known cause including but not limited to thalassemia; hypothyroidism, autoimmune or hereditary hemolytic anemia, any type of known clinically significant bleeding or sequestration or drug induced anemia, hemolytic anemia, bleeding events, or other deficiencies (that is, iron, folate, or vitamin B12). 5. Clinically significant cardiovascular disease defined as: 1. New York Heart Association heart disease class III or IV 2. Fridericia corrected QT (QTcF) interval \>500 milliseconds during screening 3. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening 6. Known ejection fraction \<35%, confirmed by a local echocardiogram performed during screening, or a previously performed echocardiogram if collected within 6 months before screening. 7. Medical history of thromboembolic events within 6 months before screening, including history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (DVT; including proximal and distal), pulmonary or arterial embolism, arterial thrombosis or other venous thrombosis. Pa
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What it tests

  • Elritercept
  • Epoetin Alfa
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Where

162 sites
Banner MD Anderson Cancer Center
Gilbert, United States
City of Hope - Comprehensive Cancer Center (CCC)
Duarte, United States
Providence Medical Group
Santa Rosa, United States
Cancer & Blood Research Center
Whittier, United States
Yale
New Haven, United States
University of Miami
Miami, United States
BRCR Medical Center Inc
Tamarac, United States
Moffitt Cancer Center
Tampa, United States

…and 154 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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