Condition: Myelodysplastic Syndromes · Del(5Q) · Anemia · Sponsor: Associazione Qol-one
Myelodysplastic syndromes, primarily affecting older adults, are a heterogeneous group of clonal disorders of hematopoietic stem cells characterized by ineffective hematopoiesis that manifest clinically as anemia, neutropenia, and/or thrombocytopenia of variable severity; these often result in RBC- transfusion dependent (TD) anemia, increased risk of infection, and/or hemorrhage, as well as a potential to progress to acute myeloid leukemia (AML). Lenalidomide is approved for red blood cell transfusion-dependent (RBC TD) anemia due to low-risk myelodysplastic syndromes (MDS) with a chromosome 5q deletion (del5q) with or without additional cytogenetic abnormalities. About one third of patients are refractory/resistant/intolerant and will require further treatment options. Luspatercept (ACE-536), an erythroid maturation agent, is a recombinant fusion protein consisting of a modified form of the extracellular domain (ECD) of the human activin receptor type IIB (ActRIIB) linked to the Fc portion of human immunoglobulin G1 (IgG1-Fc). Luspatercept acts on endogenous inhibitors of late-stage erythropoiesis (eg, growth differentiation factor 11, GDF11) to increase release of mature erythrocytes into circulation. Nonclinical data have demonstrated that luspatercept binds to negative regulators governing late-stage erythroid development to inhibit their action, thereby promoting the maturation of erythrocytes in the bone marrow. Luspatercept is indicated for the treatment of adult pa…
This description comes directly from the study's public registry record.
Esther N Oliva, MD · +393298699514 · trials@qol-one.org
Always discuss trial participation with your own doctor first.
| A.O. SS. Antonio e Biagio e Cesare Arrigo Ospedale Civile | Alessandria, Italy | Not Yet Recruiting |
| A.O.U. Ospedali Riuniti | Ancona, Italy | Recruiting |
| A.O. S. Giuseppe Moscati | Avellino, Italy | Not Yet Recruiting |
| Ospedale degli Infermi | Biella, Italy | Not Yet Recruiting |
| A.O.U. G. Rodolico San Marco | Catania, Italy | Not Yet Recruiting |
| ARNAS Garibaldi, PO Nesima | Catania, Italy | Not Yet Recruiting |
| ASL TO 4 - Ospedale Chivasso | Chivasso, Italy | Not Yet Recruiting |
| Azienda Ospedaliera Annunziata | Cosenza, Italy | Not Yet Recruiting |
| A.O.U. Careggi | Florence, Italy | Not Yet Recruiting |
| A.O.U. Federico II | Naples, Italy | Not Yet Recruiting |
| A.O.U. Maggiore della Carità | Novara, Italy | Not Yet Recruiting |
| A.O.U. Policlinico Paolo Giaccone | Palermo, Italy | Not Yet Recruiting |
+ 11 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05924100