{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T05:46:12Z","timestamp":1790142372626,"version":"4.0.1"},"reference-count":21,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2020,2,11]],"date-time":"2020-02-11T00:00:00Z","timestamp":1581379200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100002429","name":"Amgen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2020,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Adult patients with relapsed\/refractory (R\/R) B\u2010precursor acute lymphoblastic leukemia (ALL) have a poor prognosis. Blinatumomab is a bispecific T\u2010cell engager (BiTE) immuno\u2010oncology therapy with dual specificity for CD19 and CD3 that redirects patients\u2019 CD3\u2010positive cytotoxic T cells to lyse malignant and normal B cells. We conducted an open\u2010label, phase 1b\/2 study to determine the safety, pharmacokinetics, efficacy and recommended dose of blinatumomab in Japanese adults with R\/R B\u2010precursor ALL. Patients received 9\u00a0\u03bcg\/day blinatumomab during week 1 and 28\u00a0\u03bcg\/day during weeks 2\u20104, with a 2\u2010week treatment\u2010free interval (6\u2010week cycle); patients received 28\u00a0\u03bcg\/day blinatumomab in subsequent cycles. Primary endpoints were the incidence of dose\u2010limiting toxicities (DLT) in phase 1b and complete remission (CR)\/CR with partial hematologic recovery (CRh) within the first two cycles in phase 2. A total of 26 patients enrolled and 25 (96%) reported grade \u22653 adverse events (mostly cytopenias). There were no DLT. CR\/CRh within two cycles was achieved by 4 of 5 patients (80%) in phase 1b and 8 of 21 patients (38%) in phase 2. Among patients with evaluable minimal residual disease, 4 (100%) in phase 1b and 3 (38%) in phase 2 had a complete MRD response. Median RFS for 8 patients who achieved CR\/CRh in phase 2 was 5 (95% CI: 3.5\u20106.4) months; median OS was not estimable. There were no significant associations between maximum cytokine levels or percentage of specific cell types during cycle 1 and response. Consistent with global studies, blinatumomab appeared to be safe and efficacious in Japanese adults with R\/R ALL.<\/jats:p>","DOI":"10.1111\/cas.14322","type":"journal-article","created":{"date-parts":[[2020,1,23]],"date-time":"2020-01-23T05:20:20Z","timestamp":1579756820000},"page":"1314-1323","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":25,"title":["Phase 1b\/2 study of blinatumomab in Japanese adults with relapsed\/refractory acute lymphoblastic leukemia"],"prefix":"10.1111","volume":"111","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6382-9498","authenticated-orcid":false,"given":"Hitoshi","family":"Kiyoi","sequence":"first","affiliation":[{"name":"Department of Hematology and Oncology Nagoya University Graduate School of Medicine Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joan D.","family":"Morris","sequence":"additional","affiliation":[{"name":"Amgen Inc. Thousand Oaks California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iekuni","family":"Oh","sequence":"additional","affiliation":[{"name":"Jichi Medical University Tochigi\u2010ken Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshinobu","family":"Maeda","sequence":"additional","affiliation":[{"name":"Okayama University Hospital Okayama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8630-9145","authenticated-orcid":false,"given":"Hironobu","family":"Minami","sequence":"additional","affiliation":[{"name":"Medical Oncology\/Hematology Kobe University Graduate School of Medicine and Hospital Kobe Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6533-1594","authenticated-orcid":false,"given":"Toshihiro","family":"Miyamoto","sequence":"additional","affiliation":[{"name":"Department of Medicine and Biosystemic Science Kyushu University Graduate School of Medical Science Fukuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toru","family":"Sakura","sequence":"additional","affiliation":[{"name":"Leukemia Research Center Saiseikai Maebashi Hospital Maebashi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroatsu","family":"Iida","sequence":"additional","affiliation":[{"name":"National Hospital Organization Nagoya Medical Center Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine A.","family":"Tuglus","sequence":"additional","affiliation":[{"name":"Amgen Inc. 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