{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,11]],"date-time":"2026-08-11T21:09:43Z","timestamp":1786482583382,"version":"build-2736575974"},"reference-count":43,"publisher":"S. Karger AG","issue":"6","license":[{"start":{"date-parts":[[2022,1,1]],"date-time":"2022-01-01T00:00:00Z","timestamp":1640995200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.karger.com\/Services\/SiteLicenses"},{"start":{"date-parts":[[2022,1,1]],"date-time":"2022-01-01T00:00:00Z","timestamp":1640995200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.karger.com\/Services\/SiteLicenses"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Acta Haematol"],"published-print":{"date-parts":[[2022]]},"abstract":"<b><i>Introduction:<\/i><\/b> The safety and efficacy of blinatumomab, a CD19\/CD3 bispecific T-cell engager (BiTE\u00ae) molecule, was evaluated in an expansion cohort of the phase 1b\/2 study (NCT02412306) in Japanese adult (<i>n<\/i> = 14) and pediatric (<i>n<\/i> = 17) patients with relapsed\/refractory Philadelphia-negative B-cell precursor (BCP) acute lymphoblastic leukemia (ALL). <b><i>Materials and methods:<\/i><\/b> Globally recommended blinatumomab doses were administered to adult (9\u201328 \u03bcg\/day) and pediatric (5\u201315 \u03bcg\/m<sup>2<\/sup>\/day) patients. Primary endpoint was the incidence of treatment-emergent adverse events (TEAEs) and treatment-related AEs. <b><i>Results:<\/i><\/b> All adult and pediatric patients experienced \u22651 TEAE. Grade \u22653 TEAEs were observed in 11 (79%) adult and 15 (88%) pediatric patients. Blinatumomab was discontinued in 1 (6%) pediatric patient due to treatment-related grade 4 cytokine release syndrome. Fatal AEs such as disease progression and multiple-organ dysfunction syndrome, which were not treatment-related, were reported in 2 (12%) pediatric patients. Eleven (79%) adults achieved complete remission (CR)\/CR with partial hematological recovery (CRh) within the first two blinatumomab cycles. Nine of 10 adult patients with CR\/CRh and evaluable minimal residual disease (MRD) achieved MRD response. CR\/CRh was achieved by 5 (29%) pediatric patients, of which two had MRD response. <b><i>Conclusion:<\/i><\/b> In conclusion, blinatumomab was safe and efficacious in Japanese patients with relapsed\/refractory BCP ALL. <\/jats:p>","DOI":"10.1159\/000525835","type":"journal-article","created":{"date-parts":[[2022,7,5]],"date-time":"2022-07-05T21:00:31Z","timestamp":1657054831000},"page":"592-602","source":"Crossref","is-referenced-by-count":4,"title":["Safety and Efficacy of Blinatumomab in Japanese Adult and Pediatric Patients with Relapsed\/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia: Final Results from an Expansion Cohort"],"prefix":"10.1159","volume":"145","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6737-1509","authenticated-orcid":false,"given":"Hiroaki","family":"Goto","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chitose","family":"Ogawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3238-9087","authenticated-orcid":false,"given":"Hiroatsu","family":"Iida","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keizo","family":"Horibe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iekuni","family":"Oh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoru","family":"Takada","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshinobu","family":"Maeda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hironobu","family":"Minami","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3025-723X","authenticated-orcid":false,"given":"Yasuhiro","family":"Nakashima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joan D.","family":"Morris","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Kormany","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuqi","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshihiro","family":"Miyamoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"127","published-online":{"date-parts":[[2022,7,5]]},"reference":[{"key":"ref1"},{"key":"ref2"},{"key":"ref3"},{"key":"ref4"},{"key":"ref5"},{"key":"ref6"},{"key":"ref7"},{"key":"ref8"},{"key":"ref9"},{"key":"ref10"},{"key":"ref11"},{"key":"ref12"},{"key":"ref13"},{"key":"ref14"},{"key":"ref15"},{"key":"ref16"},{"key":"ref17"},{"key":"ref18"},{"key":"ref19"},{"key":"ref20"},{"key":"ref21"},{"key":"ref22"},{"key":"ref23"},{"key":"ref24"},{"key":"ref25"},{"key":"ref26"},{"key":"ref27"},{"key":"ref28"},{"key":"ref29"},{"key":"ref30"},{"key":"ref31"},{"key":"ref32"},{"key":"ref33"},{"key":"ref34"},{"key":"ref35"},{"key":"ref36"},{"key":"ref37"},{"key":"ref38"},{"key":"ref39"},{"key":"ref40"},{"key":"ref41"},{"key":"ref42"},{"key":"ref43"}],"container-title":["Acta Haematologica"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.karger.com\/Article\/Pdf\/525835","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.karger.com\/Article\/Pdf\/525835","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,23]],"date-time":"2025-04-23T15:09:57Z","timestamp":1745420997000},"score":1,"resource":{"primary":{"URL":"https:\/\/karger.com\/article\/doi\/10.1159\/000525835"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022]]},"references-count":43,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2022,11,23]]},"published-print":{"date-parts":[[2022,11,23]]}},"URL":"https:\/\/doi.org\/10.1159\/000525835","archive":["Portico"],"relation":{"is-supplemented-by":[{"id-type":"doi","id":"10.6084\/m9.figshare.20226060","asserted-by":"subject"}]},"ISSN":["0001-5792","1421-9662"],"issn-type":[{"value":"0001-5792","type":"print"},{"value":"1421-9662","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022]]}}}