{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T09:12:59Z","timestamp":1792141979773,"version":"4.4.0"},"reference-count":22,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"2","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2025,1,10]]},"abstract":"\n PURPOSE<\/jats:title>\n \n Older patients with relapsed or refractory AML (RR AML) have dismal prognoses without allogeneic hematopoietic cell transplantation (alloHCT). SIERRA compared a targeted pretransplant regimen involving the anti-CD45 radioconjugate\n 131<\/jats:sup>\n I-apamistamab with conventional care.\n <\/jats:p>\n <\/jats:sec>\n \n METHODS<\/jats:title>\n \n SIERRA (ClinicalTrials.gov identifier:\n NCT02665065<\/jats:ext-link>\n ) was a phase III open-label trial. Patients age \u226555 years with active RR AML were randomly assigned 1:1 to either an\n 131<\/jats:sup>\n I-apamistamab\u2013led regimen before alloHCT or conventional care followed by alloHCT if initial complete remission (CR)\/CR with incomplete platelet recovery (CRp) occurred. Initial response was assessed 28-56 days after alloHCT in the\n 131<\/jats:sup>\n I-apamistamab group and 28-42 days after salvage chemotherapy initiation; patients without CR\/CRp or with AML progression could cross over to receive\n 131<\/jats:sup>\n I-apamistamab followed by alloHCT. The primary end point was durable complete remission (dCR) lasting 180 days after initial CR\/CRp. Secondary end points were overall survival (OS) and event-free survival (EFS), assessed hierarchically in the intention-to-treat (ITT) population.\n <\/jats:p>\n <\/jats:sec>\n \n RESULTS<\/jats:title>\n \n The ITT population included 153 patients (\n 131<\/jats:sup>\n I-apamistamab [n = 76]; conventional care [n = 77]). In total, 44\/77 conventional care arm patients crossed over and 40\/77 (52%) received\n 131<\/jats:sup>\n I-apamistamab and alloHCT, with six patients (13.6%) experiencing a dCR. In the ITT population, the dCR rate was significantly higher with\n 131<\/jats:sup>\n I-apamistamab (17.1% [95% CI, 9.4 to 27.5]) than conventional care (0% [95% CI, 0 to 4.7];\n P<\/jats:italic>\n < .0001). The OS hazard ratio (HR) was 0.99 (95% CI, 0.70 to 1.41;\n P<\/jats:italic>\n = .96), and the EFS HR was 0.23 (95% CI, 0.15 to 0.34), with HR <1 favoring\n 131<\/jats:sup>\n I-apamistamab. Grade \u22653 treatment-related adverse events occurred in 59.7% and 59.2% of the\n 131<\/jats:sup>\n I-apamistamab and conventional care groups, respectively.\n <\/jats:p>\n <\/jats:sec>\n \n CONCLUSION<\/jats:title>\n \n The\n 131<\/jats:sup>\n I-apamistamab\u2013led regimen was associated with a higher dCR rate than conventional care in older patients with RR AML.\n 131<\/jats:sup>\n I-apamistamab was well tolerated and could address an unmet need in this population.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1200\/jco.23.02018","type":"journal-article","created":{"date-parts":[[2024,9,19]],"date-time":"2024-09-19T20:12:48Z","timestamp":1726776768000},"page":"201-213","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":21,"title":["Randomized Phase III SIERRA Trial of\n 131<\/sup>\n I-Apamistamab Before Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care for Relapsed\/Refractory AML"],"prefix":"10.1200","volume":"43","clinical-trial-number":[{"clinical-trial-number":"nct02665065","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2933-2119","authenticated-orcid":true,"given":"Boglarka","family":"Gyurkocza","sequence":"first","affiliation":[{"name":"David H. 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