{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T23:31:45Z","timestamp":1793316705884,"version":"4.5.0"},"reference-count":14,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"5","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["J Clin Oncol"],"published-print":{"date-parts":[[2026,2,10]]},"abstract":"<jats:p>\n                    <jats:italic toggle=\"yes\">KMT2A<\/jats:italic>\n                    -rearranged infant ALL (\n                    <jats:italic toggle=\"yes\">KMT2A<\/jats:italic>\n                    -r ALL) has a poor prognosis. Adding blinatumomab, a bispecific T-cell engager targeting CD19, to standard chemotherapy for infants with\n                    <jats:italic toggle=\"yes\">KMT2A<\/jats:italic>\n                    -r ALL improved short-term outcomes. Here, we present long-term results, toxicity, and pharmacokinetics of blinatumomab from this study. Thirty infants received Interfant-06 protocol chemotherapy with one additional postinduction blinatumomab course. Disease-free survival (DFS) and overall survival (OS) were compared with a historical Interfant-06\u2013selected cohort without blinatumomab. Infection and administration of intravenous immunoglobulin (IVIg) and granulocyte-colony stimulating factor (G-CSF) were documented. Blinatumomab's steady-state concentration (Css) and clearance (CL) were analyzed. The median follow-up was 4.2 years (range, 3.2-6.0). Blinatumomab significantly improved outcomes compared with controls, with a 4-year DFS of 83.3% versus 44.0% and a 4-year OS of 93.3% versus 60.2%. No infection-related fatality occurred postinduction, in contrast to 4% in Interfant-06. IVIg was administered in 19 (63%) patients, and G-CSF in five (17%). The mean Css of blinatumomab was 706 \u00b1 194 pg\/mL\/d, and the median CL was 0.89 L\/h\/m\n                    <jats:sup>2<\/jats:sup>\n                    (range, 0.57-2.66). Adding blinatumomab to standard treatment for infants with\n                    <jats:italic toggle=\"yes\">KMT2A<\/jats:italic>\n                    -r ALL resulted in sustained improvement in outcome. Pharmacokinetics were comparable across pediatric age groups. The benefit of blinatumomab in frontline therapy remains promising and awaits further confirmation in ongoing trials.\n                  <\/jats:p>","DOI":"10.1200\/jco-25-01806","type":"journal-article","created":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T21:00:32Z","timestamp":1767906032000},"page":"370-374","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":12,"title":["Sustained Benefit of Blinatumomab in Infants With\n                    <i>KMT2A<\/i>\n                    -Rearranged ALL: Long-Term Outcomes, Toxicity, and Pharmacokinetics"],"prefix":"10.1200","volume":"44","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3021-2843","authenticated-orcid":true,"given":"Miguel","family":"Vieira Martins","sequence":"first","affiliation":[{"name":"Princess M\u00e1xima Center for Pediatric Oncology, Utrecht, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-7522-5195","authenticated-orcid":true,"given":"Paola","family":"de Lorenzo","sequence":"additional","affiliation":[{"name":"Biostatistics and Clinical Epidemiology, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1836-4075","authenticated-orcid":true,"given":"Rishi S.","family":"Kotecha","sequence":"additional","affiliation":[{"name":"Australian and New Zealand Children's Hematology and Oncology Group, Perth, Australia"},{"name":"Children's Hospital and University of Western Australia, Perth, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9285-6898","authenticated-orcid":true,"given":"Andishe","family":"Attarbaschi","sequence":"additional","affiliation":[{"name":"Department of Pediatric Hematology and Oncology, St Anna Children's Hospital, Vienna, Austria"},{"name":"Medical University of Vienna, and St Anna Children's Cancer Research Institute, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriele","family":"Escherich","sequence":"additional","affiliation":[{"name":"German Cooperative Study Group for Childhood Acute Lymphoblastic Leukemia, Hamburg, Germany"},{"name":"Clinic of Pediatric Hematology and Oncology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2935-0058","authenticated-orcid":true,"given":"Karsten","family":"Nysom","sequence":"additional","affiliation":[{"name":"Department of Pediatrics and Adolescent Medicine, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6818-7743","authenticated-orcid":false,"given":"Jan","family":"Stary","sequence":"additional","affiliation":[{"name":"Czech Working Group for Pediatric Hematology and CLIP (Childhood Leukemia Investigation Prague), Prague, Czechia"},{"name":"Department of Pediatric Hematology and Oncology, Second Faculty of Medicine, Charles University and University Hospital Motol, Prague, Czechia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alina","family":"Ferster","sequence":"additional","affiliation":[{"name":"H\u00f4pital Universitaire des Enfants Reine Fabiola, Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benoit","family":"Brethon","sequence":"additional","affiliation":[{"name":"Department of Pediatric Hematology, University Robert Debre Hospital, Assistance Publique-H\u00f4pitaux de Paris, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7976-3654","authenticated-orcid":true,"given":"Franco","family":"Locatelli","sequence":"additional","affiliation":[{"name":"Department of Pediatric Hematology-Oncology and Cell and Gene Therapy, IRCCS Ospedale Pediatrico Bambino Ges\u00f9, Catholic University of the Sacred Heart, Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0034-5845","authenticated-orcid":true,"given":"Martin","family":"Schrappe","sequence":"additional","affiliation":[{"name":"ALL-Berlin-Frankfurt-M\u00fcnster (BFM) Group, University Medical Center Schleswig-Holstein, Kiel, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peggy E.","family":"Scholte-van Houtem","sequence":"additional","affiliation":[{"name":"Princess M\u00e1xima Center for Pediatric Oncology, Utrecht, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5574-3504","authenticated-orcid":true,"given":"Maria G.","family":"Valsecchi","sequence":"additional","affiliation":[{"name":"Biostatistics and Clinical Epidemiology, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alwin D.R.","family":"Huitema","sequence":"additional","affiliation":[{"name":"Princess M\u00e1xima Center for Pediatric Oncology, Utrecht, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2997-3570","authenticated-orcid":true,"given":"Rob","family":"Pieters","sequence":"additional","affiliation":[{"name":"Princess M\u00e1xima Center for Pediatric Oncology, Utrecht, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5822-7668","authenticated-orcid":true,"given":"Inge M.","family":"van der Sluis","sequence":"additional","affiliation":[{"name":"Princess M\u00e1xima Center for Pediatric Oncology, Utrecht, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"e_1_3_10_2_2","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2023023154"},{"key":"e_1_3_10_3_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.23.01286"},{"key":"e_1_3_10_4_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.19.00261"},{"key":"e_1_3_10_5_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2411680"},{"key":"e_1_3_10_6_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2214171"},{"key":"e_1_3_10_7_2","doi-asserted-by":"publisher","DOI":"10.1002\/sim.1357"},{"key":"e_1_3_10_8_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2016.67.3301"},{"key":"e_1_3_10_9_2","volume-title":"Committee for Medicinal Products for Human Use (CHMP) Assessment Report\u2014Blincyto","author":"European Medicines Agency","year":"2018","unstructured":"European Medicines Agency: Committee for Medicinal Products for Human Use (CHMP) Assessment Report\u2014Blincyto. 2018. https:\/\/www.ema.europa.eu\/en\/documents\/variation-report\/blincyto-h-c-3731-ii-0018-epar-assessment-report-variation_en.pdf"},{"key":"e_1_3_10_10_2","unstructured":"European Medicines Agency: Blincyto [product information]. August 23 2018. https:\/\/www.ema.europa.eu\/en\/documents\/variation-report\/blincyto-h-c-3731-ii-0018-epar-assessment-report-variation_en.pdf"},{"key":"e_1_3_10_11_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2021.0987"},{"key":"e_1_3_10_12_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-016-0405-4"},{"key":"e_1_3_10_13_2","unstructured":"Food and Drug Administration: FDA approves blinatumomab as consolidation for CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia. 2024. https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-blinatumomab-consolidation-cd19-positive-philadelphia-chromosome-negative-b-cell"},{"key":"e_1_3_10_14_2","volume-title":"Interfant-21 Treatment Protocol for Infants Under 1 Year with KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia (Interfant-21)","author":"ClinicalTrials.gov","year":"2022","unstructured":"ClinicalTrials.gov: Interfant-21 Treatment Protocol for Infants Under 1 Year with KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia (Interfant-21). 2022. https:\/\/clinicaltrials.gov\/study\/NCT05327894?cond=NCT05327894&rank=1"},{"key":"e_1_3_10_15_2","volume-title":"Testing the Addition of the Anti-cancer Drug Venetoclax and\/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants with Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia","author":"ClinicalTrials.gov","year":"2025","unstructured":"ClinicalTrials.gov: Testing the Addition of the Anti-cancer Drug Venetoclax and\/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants with Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia. 2025. https:\/\/clinicaltrials.gov\/study\/NCT06317662"}],"container-title":["Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JCO-25-01806","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,2,5]],"date-time":"2026-02-05T23:00:29Z","timestamp":1770332429000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JCO-25-01806"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2,10]]},"references-count":14,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2026,2,10]]}},"alternative-id":["10.1200\/JCO-25-01806"],"URL":"https:\/\/doi.org\/10.1200\/jco-25-01806","relation":{},"ISSN":["0732-183X","1527-7755"],"issn-type":[{"value":"0732-183X","type":"print"},{"value":"1527-7755","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2,10]]},"assertion":[{"value":"2025-07-30","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-09-27","order":1,"name":"revised","label":"Revised","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-10-24","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-01-08","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}