This phase II MyeloMATCH treatment trial tests luspatercep with or without epoetin alfa or emavusertib for the treatment of low risk myelodysplasia and anemia. Biological therapies, such as luspatercep, use substances made from living organisms that may attack specific cancer cells and stop them from growing or kill them. Epoetin alfa is a substance that is made in the laboratory and stimulates the bone marrow to make red blood cells. Emavusertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving luspatercep with or without epoetin alfa or emavusertib may be effective for treating patients with low risk myelodysplasia and anemia.
Participants must have been registered to Master Screening and Re-Assessment Protocol (MYELOMATCH) prior to consenting to this study. Participants must have been assigned to this clinical trial, via MATCHBox Protocol Assignment Team, prior to registration to this study. Participants must have agreed to have specimens submitted for translational medicine and must be offered the opportunity to submit biosamples for banking for future research as per MYELOMATCH
Participants must have pathologically confirmed MDS according to World Health Organization (WHO) 2022 classification, without excess blasts
Lower risk MDS with a revised international prognostic scoring system (IPSS-R) score of less than or equal to 3.5
Symptomatic anemia defined as either red blood cell (RBC) transfusion dependent, or hemoglobin < 95 g/L with subjective fatigue or dyspnea
Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
MDS with del(5q)
Concurrent use of hematopoietic growth factors (other than protocol specified)
Known hypersensitivity to either luspatercept, erythropoietin, or emavusertib therapy
Parallel
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Bone Marrow Aspiration
Procedure/SurgeryUndergo bone marrow aspiration
Emavusertib
Biological/VaccineGiven PO
Epoetin Alfa
Biological/VaccineGiven SC
Luspatercept
Biological/VaccineGiven SC
Erythroid response rate
Defined by the total number of patients with hematologic improvement-erythroid (HI-E) response divided by the total number of randomized patients in each arm. The comparison of the HI-E rate will be done using a Cochran-Mantel-Haenszel test stratified for the stratification factors at randomization based on the intent-to-treat population. The difference in the response rates and the corresponding one-sided 90% confidence limit will be calculated.
Transfusion free survival
Defined as from achieving transfusion independence to the first day of transfusions after becoming transfusion dependent as defined by International Working Group (IWG) 2018 criteria for those who are transfusion dependent at enrollment or time to first day of transfusions as defined by IWG 2018 criteria for those nor transfusion dependent at enrollment.
Duration of erythroid response
Tri-lineage response
Tri-lineage response involves erythroid, neutrophil, and platelet response per IWG 2018 criteria.
Bi-lineage response
Any two of the responses for erythroid, neutrophil, and platelet response per IWG 2018 criteria.
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