{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T22:52:42Z","timestamp":1791240762062,"version":"4.1.0"},"reference-count":25,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2024,2,5]],"date-time":"2024-02-05T00:00:00Z","timestamp":1707091200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100016579","name":"Amgen Astellas Biopharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100016579","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["American J Hematol"],"published-print":{"date-parts":[[2024,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Blinatumomab is a BiTE\u00ae (bispecific T\u2010cell engager) molecule that redirects CD3<jats:sup>+<\/jats:sup> T\u2010cells to engage and lyse CD19<jats:sup>+<\/jats:sup> target cells. Here we demonstrate that subcutaneous (SC) blinatumomab can provide high efficacy and greater convenience of administration. In the expansion phase of a multi\u2010institutional phase 1b trial (ClinicalTrials.gov, NCT04521231), heavily pretreated adults with relapsed\/refractory B\u2010cell acute lymphoblastic leukemia (R\/R B\u2010ALL) received SC blinatumomab at two doses: (1) 250\u2009\u03bcg once daily (QD) for week 1 and 500\u2009\u03bcg three times weekly (TIW) thereafter (250\u2009\u03bcg\/500\u2009\u03bcg) or (2) 500\u2009\u03bcg QD for week 1 and 1000\u2009\u03bcg TIW thereafter (500\u2009\u03bcg\/1000\u2009\u03bcg). The primary endpoint was complete remission\/complete remission with partial hematologic recovery (CR\/CRh) within two cycles. At the data cutoff of September 15, 2023, 29 patients were treated: 14 at the 250\u2009\u03bcg\/500\u2009\u03bcg dose and 13 at 500\u2009\u03bcg\/1000\u2009\u03bcg dose. Data from two ineligible patients were excluded. At the end of two cycles, 12 of 14 patients (85.7%) from the 250\u2009\u03bcg\/500\u2009\u03bcg dose achieved CR\/CRh of which nine patients (75.0%) were negative for measurable residual disease (MRD; &lt;10<jats:sup>\u22124<\/jats:sup> leukemic blasts). At the 500\u2009\u03bcg\/1000\u2009\u03bcg dose, 12 of 13 patients (92.3%) achieved CR\/CRh; all 12 patients (100.0%) were MRD\u2010negative. No treatment\u2010related grade 4 cytokine release syndrome (CRS) or neurologic events (NEs) were reported. SC injections were well tolerated and all treatment\u2010related grade 3 CRS and NEs responded to standard\u2010of\u2010care management, interruption, or discontinuation. Treatment with SC blinatumomab resulted in high efficacy, with high MRD\u2010negativity rates and acceptable safety profile in heavily pretreated adults with R\/R B\u2010ALL.<\/jats:p>","DOI":"10.1002\/ajh.27227","type":"journal-article","created":{"date-parts":[[2024,2,7]],"date-time":"2024-02-07T07:10:05Z","timestamp":1707289805000},"page":"586-595","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":65,"title":["Single agent subcutaneous blinatumomab for advanced acute lymphoblastic leukemia"],"prefix":"10.1002","volume":"99","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4465-6119","authenticated-orcid":false,"given":"Elias","family":"Jabbour","sequence":"first","affiliation":[{"name":"Department of Leukemia The University of Texas MD Anderson Cancer Center  Houston Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerhard","family":"Zugmaier","sequence":"additional","affiliation":[{"name":"Amgen Research (Munich), GmbH  Munich Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6383-3777","authenticated-orcid":false,"given":"Vaibhav","family":"Agrawal","sequence":"additional","affiliation":[{"name":"Department of Hematology and Hematopoietic Cell Transplantation Gehr Family Center for Leukemia Research, City of Hope National Medical Center  Duarte California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pilar","family":"Mart\u00ednez\u2010S\u00e1nchez","sequence":"additional","affiliation":[{"name":"Department of Hematology Hospital Universitario 12 de Octubre, Instituto de Investigaci\u00f3n Sanitaria Hospital 12 de Octubre (imas12), CNIO, CIBERONC  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9 J.","family":"Rif\u00f3n Roca","sequence":"additional","affiliation":[{"name":"Hematology and Hemotherapy Department Cl\u00ednica Universidad de Navarra  Pamplona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3424-2425","authenticated-orcid":false,"given":"Ryan D.","family":"Cassaday","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology, Department of Medicine University of Washington School of Medicine  Seattle Washington USA"},{"name":"Clinical Research Division Fred Hutchinson Cancer Center  Seattle Washington USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Boris","family":"B\u00f6ll","sequence":"additional","affiliation":[{"name":"First Department of Internal Medicine Center for Integrated Oncology Aachen Bonn Cologne Dusseldorf, University of Cologne  Cologne Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anita","family":"Rijneveld","sequence":"additional","affiliation":[{"name":"Department of Hematology Erasmus University Medical Center Cancer Institute  Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maher","family":"Abdul\u2010Hay","sequence":"additional","affiliation":[{"name":"Perlmutter Cancer Center New York University Langone Health  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fran\u00e7oise","family":"Huguet","sequence":"additional","affiliation":[{"name":"Department of Hematology Institut Universitaire du Cancer\u2010Oncopole CHU de Toulouse  Toulouse France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Cluzeau","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Nice C\u00f4te d'Azur, CHU de Nice  Nice France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar Tormo","family":"D\u00edaz","sequence":"additional","affiliation":[{"name":"Hematology Department Hospital Cl\u00ednico Universitario de Valencia, Instituto de Investigaci\u00f3n Sanitaria INCLIVA  Valencia Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vladan","family":"Vucinic","sequence":"additional","affiliation":[{"name":"Department of Hematology and Cell Therapy University Hospital Leipzig  Leipzig Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9","family":"Gonz\u00e1lez\u2010Campos","sequence":"additional","affiliation":[{"name":"Hematology Department Hospital Universitario Virgen del Roc\u00edo  Sevilla Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro","family":"Rambaldi","sequence":"additional","affiliation":[{"name":"Department of Oncology\u2010Hematology University of Milan, Milan and Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII  Bergamo Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan","family":"Schwartz","sequence":"additional","affiliation":[{"name":"Department of Hematology, Oncology and Tumor Immunology Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin, corporate member of Freie Universit\u00e4t and Humboldt\u2010Universit\u00e4t zu Berlin, Campus Benjamin Franklin  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C\u00e9line","family":"Berthon","sequence":"additional","affiliation":[{"name":"Centre Hospitalier Universitaire de Lille  Lille France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9661-9371","authenticated-orcid":false,"given":"Jes\u00fas Mar\u00eda","family":"Hern\u00e1ndez\u2010Rivas","sequence":"additional","affiliation":[{"name":"IBSAL, IBMCC, CSIC, Cancer Research Center, University of Salamanca  Salamanca Spain"},{"name":"Department of Hematology University Hospital of Salamanca  Salamanca Spain"},{"name":"CIBERONC, Research Group CB16\/12\/00233  Salamanca Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul R.","family":"Gordon","sequence":"additional","affiliation":[{"name":"Amgen Inc.  Thousand Oaks California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monika","family":"Br\u00fcggemann","sequence":"additional","affiliation":[{"name":"Department of Hematology University of Schleswig\u2010Holstein  Kiel Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ali","family":"Hamidi","sequence":"additional","affiliation":[{"name":"Amgen Inc.  Thousand Oaks California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuqi","family":"Chen","sequence":"additional","affiliation":[{"name":"Amgen Inc.  Thousand Oaks California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hansen L.","family":"Wong","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology, Modeling and Simulation, Amgen Inc.  South San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bharat","family":"Panwar","sequence":"additional","affiliation":[{"name":"Amgen Inc.  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