{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,22]],"date-time":"2026-01-22T01:20:28Z","timestamp":1769044828004,"version":"3.49.0"},"reference-count":10,"publisher":"American Society of Hematology","issue":"7","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2020,4,14]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>In a phase 3 clinical study of heavily pretreated adults with relapsed\/refractory (R\/R) acute lymphoblastic leukemia (ALL), overall survival (OS) following blinatumomab, a BiTE (bispecific T-cell engager) immunooncology therapy, was significantly improved vs chemotherapy following induction (cycles 1 to 2). Here we report the efficacy and safety of those who received additional cycles of blinatumomab. Blinatumomab was administered as a continuous IV infusion for 4 weeks in a 6-week cycle. Patients who achieved a bone marrow response (\u22645% blasts) or complete remission (full, partial, or incomplete hematological recovery) during induction could receive additional cycles of blinatumomab. OS and relapse-free survival (RFS) for consolidation (cycles 3 to 5) vs no consolidation, and maintenance (cycles \u22656) vs no maintenance were analyzed using Simon-Makuch and Mantel-Byar odds ratios. Of 267 patients who received blinatumomab induction, 86 (32%) entered consolidation and 36 (13%) entered maintenance. Evidence of longer OS was demonstrated among the maintenance group compared with no-maintenance (median OS [95% confidence interval, CI]: not reached for maintenance vs 15.5 months for no maintenance). Median RFS (months; 95% CI) was numerically longer among maintenance group (14.5; 7.1 to 21.9) compared with no-maintenance (9.8; 8.5 to 11.1). A lower incidence of adverse events was seen during maintenance (72.2%) compared with induction (97.2%) and consolidation (86.1%). Adults with R\/R ALL who achieved remission following blinatumomab induction had longer survival on continuation therapy than those who discontinued blinatumomab early, supporting the use of blinatumomab as long-term therapy. No new safety signals were reported. This trial was registered at www.clinicaltrials.gov as #NCT02013167.<\/jats:p>","DOI":"10.1182\/bloodadvances.2019000874","type":"journal-article","created":{"date-parts":[[2020,4,14]],"date-time":"2020-04-14T15:38:23Z","timestamp":1586878703000},"page":"1518-1525","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":14,"title":["Blinatumomab consolidation and maintenance therapy in adults with relapsed\/refractory B-precursor acute lymphoblastic leukemia"],"prefix":"10.1182","volume":"4","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3739-7502","authenticated-orcid":false,"given":"Alessandro","family":"Rambaldi","sequence":"first","affiliation":[{"name":"Universit\u00e0 Statale di Milano, Milan and Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9576-8578","authenticated-orcid":false,"given":"Francoise","family":"Huguet","sequence":"first","affiliation":[{"name":"Institut Universitaire du Cancer, Centre Hospitalier Universitaire de Toulouse, Toulouse, France;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4465-5343","authenticated-orcid":false,"given":"Pavel","family":"Zak","sequence":"first","affiliation":[{"name":"Fakultni Nemocnice Hradec Kr\u00e1lov\u00e9, Hradec Kr\u00e1lov\u00e9, Czech Republic;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"Cannell","sequence":"first","affiliation":[{"name":"Fiona Stanley Hospital, Perth, Australia;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qui","family":"Tran","sequence":"first","affiliation":[{"name":"Amgen Inc, Thousand Oaks, CA; and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Janet","family":"Franklin","sequence":"first","affiliation":[{"name":"Amgen Inc, Thousand Oaks, CA; and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Max S.","family":"Topp","sequence":"first","affiliation":[{"name":"Medizinische Klinik und Poliklinik II, Universit\u00e4tsklinikum W\u00fcrzburg, W\u00fcrzburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"234","published-online":{"date-parts":[[2020,4,14]]},"reference":[{"key":"2020041411381503000_B1","doi-asserted-by":"crossref","first-page":"329","DOI":"10.2147\/PROM.S149420","article-title":"Impact of blinatumomab on patient outcomes in relapsed\/refractory acute lymphoblastic leukemia: evidence to date","volume":"9","author":"Hathaway","year":"2018","journal-title":"Patient Relat Outcome Meas"},{"issue":"12","key":"2020041411381503000_B2","doi-asserted-by":"crossref","first-page":"1524","DOI":"10.3324\/haematol.2016.144311","article-title":"International reference analysis of outcomes in adults with B-precursor Ph-negative relapsed\/refractory acute lymphoblastic leukemia","volume":"101","author":"G\u00f6kbuget","year":"2016","journal-title":"Haematologica"},{"issue":"4","key":"2020041411381503000_B3","doi-asserted-by":"crossref","first-page":"289","DOI":"10.1007\/s11899-018-0457-7","article-title":"Novel therapies in acute lymphoblastic leukemia","volume":"13","author":"Phelan","year":"2018","journal-title":"Curr Hematol Malig Rep"},{"key":"2020041411381503000_B4","volume-title":"BLINCYTO\u00ae (blinatumomab) package insert","year":"2018"},{"issue":"9","key":"2020041411381503000_B5","doi-asserted-by":"crossref","first-page":"836","DOI":"10.1056\/NEJMoa1609783","article-title":"Blinatumomab versus chemotherapy for advanced acute lymphoblastic leukemia","volume":"376","author":"Kantarjian","year":"2017","journal-title":"N Engl J Med"},{"issue":"1","key":"2020041411381503000_B6","doi-asserted-by":"crossref","first-page":"57","DOI":"10.1016\/S1470-2045(14)71170-2","article-title":"Safety and activity of blinatumomab for adult patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 study","volume":"16","author":"Topp","year":"2015","journal-title":"Lancet Oncol"},{"issue":"1","key":"2020041411381503000_B7","doi-asserted-by":"crossref","first-page":"35","DOI":"10.1002\/sim.4780030106","article-title":"A non-parametric graphical representation of the relationship between survival and the occurrence of an event: application to responder versus non-responder bias","volume":"3","author":"Simon","year":"1984","journal-title":"Stat Med"},{"issue":"345","key":"2020041411381503000_B8","doi-asserted-by":"crossref","first-page":"81","DOI":"10.1080\/01621459.1974.10480131","article-title":"Evaluation of response-time data involving transient states: an illustration using heart-transplant data","volume":"69","author":"Mantel","year":"1974","journal-title":"J Am Stat Assoc"},{"issue":"5","key":"2020041411381503000_B9","doi-asserted-by":"crossref","first-page":"587","DOI":"10.1007\/s40264-018-0760-1","article-title":"Benefit-risk assessment of blinatumomab in the treatment of relapsed\/refractory B-cell precursor acute lymphoblastic leukemia","volume":"42","author":"Stein","year":"2019","journal-title":"Drug Saf"},{"issue":"13","key":"2020041411381503000_B10","doi-asserted-by":"crossref","first-page":"1522","DOI":"10.1182\/bloodadvances.2018019034","article-title":"Exposure-adjusted adverse events comparing blinatumomab with chemotherapy in advanced acute lymphoblastic leukemia","volume":"2","author":"Stein","year":"2018","journal-title":"Blood Adv"}],"container-title":["Blood Advances"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/ashpublications.org\/bloodadvances\/article-pdf\/4\/7\/1518\/1724271\/advancesadv2019000874.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"http:\/\/ashpublications.org\/bloodadvances\/article-pdf\/4\/7\/1518\/1724271\/advancesadv2019000874.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,4,14]],"date-time":"2020-04-14T15:38:28Z","timestamp":1586878708000},"score":1,"resource":{"primary":{"URL":"https:\/\/ashpublications.org\/bloodadvances\/article\/4\/7\/1518\/454370\/Blinatumomab-consolidation-and-maintenance-therapy"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,4,14]]},"references-count":10,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2020,4,14]]}},"URL":"https:\/\/doi.org\/10.1182\/bloodadvances.2019000874","relation":{},"ISSN":["2473-9529","2473-9537"],"issn-type":[{"value":"2473-9529","type":"print"},{"value":"2473-9537","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,4,14]]}}}