{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T05:04:03Z","timestamp":1789016643357,"version":"build-2803163510"},"reference-count":25,"publisher":"Oxford University Press (OUP)","license":[{"start":{"date-parts":[[2022,7,9]],"date-time":"2022-07-09T00:00:00Z","timestamp":1657324800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/100009619","name":"Japan Agency for Medical Research and Development","doi-asserted-by":"publisher","award":["JP20ck0106604"],"award-info":[{"award-number":["JP20ck0106604"]}],"id":[{"id":"10.13039\/100009619","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009619","name":"Japan Agency for Medical Research and Development","doi-asserted-by":"publisher","award":["JP21kk0305014"],"award-info":[{"award-number":["JP21kk0305014"]}],"id":[{"id":"10.13039\/100009619","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>The purpose of this study is to establish a treatment with appropriate intensity for children (&amp;lt;16\u00a0years old at diagnosis) with de novo acute myeloid leukemia (excluding acute promyelocytic leukemia and myeloid leukemia associated with Down syndrome) according to a risk stratification based on recurrent leukemic cytogenetic abnormalities and flow-cytometric minimal residual disease at end of initial induction chemotherapy and to validate the safety and efficacy of gemtuzumab ozogamicin (GO)-combined post-induction chemotherapy for the non-low-risk (non-LR) patients. The primary endpoint of this phase III study is three-year disease-free survival rate, which will be compared between the GO and non-GO arms of the non-LR (intermediate-risk and high-risk [HR]) patients. All HR patients will be allocated to allogeneic hematopoietic stem cell transplantation in first remission. This trial has been registered at the Japan Registry of Clinical Trials (jRCTs041210015).<\/jats:p>","DOI":"10.1093\/jjco\/hyac105","type":"journal-article","created":{"date-parts":[[2022,7,9]],"date-time":"2022-07-09T23:45:50Z","timestamp":1657410350000},"source":"Crossref","is-referenced-by-count":4,"title":["A phase III clinical trial evaluating efficacy and safety of minimal residual disease-based risk stratification for children with acute myeloid leukemia, incorporating a randomized study of gemtuzumab ozogamicin in combination with post-induction chemotherapy for non-low-risk patients (JPLSG-AML-20)"],"prefix":"10.1093","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1520-7007","authenticated-orcid":false,"given":"Daisuke","family":"Tomizawa","sequence":"first","affiliation":[{"name":"Division of Leukemia and Lymphoma , Children\u2019s Cancer Center, , Tokyo, Japan"},{"name":"National Center for Child Health and Development , Children\u2019s Cancer Center, , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5738-4138","authenticated-orcid":false,"given":"Shin-ichi","family":"Tsujimoto","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Yokohama City University Graduate School of Medicine , Yokohama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shiro","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Department of Clinical Biostatistics , Graduate School of Medicine, , Kyoto, Japan"},{"name":"Kyoto University , Graduate School of Medicine, , Kyoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4104-6833","authenticated-orcid":false,"given":"Jun","family":"Matsubayashi","sequence":"additional","affiliation":[{"name":"Center for Clinical Research and Advanced Medicine, Shiga University of Medical Science , Otsu, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takahiro","family":"Aoki","sequence":"additional","affiliation":[{"name":"Department of Pediatrics , Graduate School of Medicine, , Chiba, Japan"},{"name":"Chiba University , Graduate School of Medicine, , Chiba, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shotaro","family":"Iwamoto","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Mie University Graduate School of Medicine , Tsu, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daisuke","family":"Hasegawa","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, St. Luke\u2019s International Hospital , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kozo","family":"Nagai","sequence":"additional","affiliation":[{"name":"Department of Pediatric Hematology\/Oncology, Shikoku Medical Center for Children and Adults , Zentsuji, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kentaro","family":"Nakashima","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Occupational and Environmental Health , Kita-Kyushu, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Kawaguchi","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology, Shizuoka Children\u2019s Hospital , Shizuoka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takao","family":"Deguchi","sequence":"additional","affiliation":[{"name":"Division of Cancer Immunodiagnostics , Children\u2019s Cancer Center, , Tokyo, Japan"},{"name":"National Center for Child Health and Development , Children\u2019s Cancer Center, , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nobutaka","family":"Kiyokawa","sequence":"additional","affiliation":[{"name":"Department of Pediatric Hematology and Oncology Research, National Research Institute for Child Health and Development , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kentaro","family":"Ohki","sequence":"additional","affiliation":[{"name":"Department of Pediatric Hematology and Oncology Research, National Research Institute for Child Health and Development , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hidefumi","family":"Hiramatsu","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Graduate School of Medicine Kyoto University , Kyoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Norio","family":"Shiba","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Yokohama City University Graduate School of Medicine , Yokohama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kiminori","family":"Terui","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Hirosaki University Graduate School of Medicine , Hirosaki, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akiko Moriya","family":"Saito","sequence":"additional","affiliation":[{"name":"Clinical Research Center, National Hospital Organization Nagoya Medical Center , Nagoya, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Motohiro","family":"Kato","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Tokyo , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Taga","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Shiga University of Medical Science , Otsu, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tsugumichi","family":"Koshinaga","sequence":"additional","affiliation":[{"name":"Department of Pediatric Surgery, Nihon University School of Medicine , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Souichi","family":"Adachi","sequence":"additional","affiliation":[{"name":"Human Health Science, Kyoto University , Kyoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2022,7,9]]},"reference":[{"key":"2022070923454508800_ref1","doi-asserted-by":"crossref","first-page":"4384","DOI":"10.1200\/JCO.2004.01.191","article-title":"Early deaths and treatment-related mortality in children undergoing therapy for acute myeloid leukemia: analysis of the multicenter clinical trials AML-BFM 93 and AML-BFM 98","volume":"22","author":"Creutzig","year":"2004","journal-title":"J Clin Oncol"},{"key":"2022070923454508800_ref2","doi-asserted-by":"crossref","first-page":"2130","DOI":"10.1038\/sj.leu.2403924","article-title":"Treatment strategy and long-term results in paediatric patients treated in consecutive UK AML trials","volume":"19","author":"Gibson","year":"2005","journal-title":"Leukemia"},{"key":"2022070923454508800_ref3","doi-asserted-by":"crossref","first-page":"4007","DOI":"10.1200\/JCO.2008.18.7948","article-title":"Risk-stratified therapy and the intensive use of cytarabine improves the outcome in childhood acute myeloid leukemia: the AML99 trial from the Japanese childhood AML cooperative study group","volume":"27","author":"Tsukimoto","year":"2009","journal-title":"J Clin Oncol"},{"key":"2022070923454508800_ref4","doi-asserted-by":"crossref","first-page":"543","DOI":"10.1016\/S1470-2045(10)70090-5","article-title":"Minimal residual disease-directed therapy for childhood acute myeloid leukaemia: results of the AML02 multicentre trial","volume":"11","author":"Rubnitz","year":"2010","journal-title":"Lancet Oncol"},{"key":"2022070923454508800_ref5","doi-asserted-by":"crossref","first-page":"2413","DOI":"10.1038\/leu.2013.153","article-title":"Excess treatment reduction including anthracyclines results in higher incidence of relapse in core binding factor acute myeloid leukemia in children","volume":"27","author":"Tomizawa","year":"2013","journal-title":"Leukemia"},{"key":"2022070923454508800_ref6","doi-asserted-by":"crossref","first-page":"e28692","DOI":"10.1002\/pbc.28692","article-title":"Attempts to optimize postinduction treatment in childhood acute myeloid leukemia without core-binding factors: a report from the Japanese Pediatric Leukemia\/lymphoma study group (JPLSG)","volume":"67","author":"Hasegawa","year":"2020","journal-title":"Pediatr Blood Cancer"},{"key":"2022070923454508800_ref7","doi-asserted-by":"crossref","first-page":"2949","DOI":"10.1200\/JCO.2015.62.8289","article-title":"Collaborative efforts driving progress in Pediatric acute myeloid Leukemia","volume":"33","author":"Zwaan","year":"2015","journal-title":"J Clin Oncol"},{"key":"2022070923454508800_ref8","doi-asserted-by":"crossref","first-page":"168","DOI":"10.1111\/bjh.14419","article-title":"Strategies for reducing the treatment-related physical burden of childhood acute myeloid leukaemia - a review","volume":"176","author":"Hasle","year":"2017","journal-title":"Br J Haematol"},{"key":"2022070923454508800_ref9","doi-asserted-by":"crossref","first-page":"393","DOI":"10.1038\/s41409-018-0273-7","article-title":"Allogeneic hematopoietic stem cell transplantation for children and adolescents with high-risk cytogenetic AML: distinctly poor outcomes of FUS-ERG-positive cases","volume":"54","author":"Tomizawa","year":"2019","journal-title":"Bone Marrow Transplant"},{"key":"2022070923454508800_ref10","doi-asserted-by":"crossref","first-page":"2489","DOI":"10.1182\/blood-2009-04-215152","article-title":"Novel prognostic subgroups in childhood 11q23\/MLL-rearranged acute myeloid leukemia: results of an international retrospective study","volume":"114","author":"Balgobind","year":"2009","journal-title":"Blood"},{"key":"2022070923454508800_ref11","doi-asserted-by":"crossref","first-page":"865","DOI":"10.3324\/haematol.2013.098517","article-title":"T(6;9)(p22;q34)\/DEK-NUP214-rearranged pediatric myeloid leukemia: an international study of 62 patients","volume":"99","author":"Sandahl","year":"2014","journal-title":"Haematologica"},{"key":"2022070923454508800_ref12","doi-asserted-by":"crossref","first-page":"3645","DOI":"10.1182\/blood-2011-04-346643","article-title":"NUP98\/NSD1 characterizes a novel poor prognostic group in acute myeloid leukemia with a distinct HOX gene expression pattern","volume":"118","author":"Hollink","year":"2011","journal-title":"Blood"},{"key":"2022070923454508800_ref13","doi-asserted-by":"crossref","first-page":"451","DOI":"10.1038\/ng.3772","article-title":"Pediatric non-down syndrome acute megakaryoblastic leukemia is characterized by distinct genomic subsets with varying outcomes","volume":"49","author":"Rooij","year":"2017","journal-title":"Nat Genet"},{"key":"2022070923454508800_ref14","doi-asserted-by":"crossref","first-page":"4452","DOI":"10.1158\/0008-5472.CAN-18-0840","article-title":"Recurrent RARB translocations in acute promyelocytic leukemia lacking RARA translocation","volume":"78","author":"Osumi","year":"2018","journal-title":"Cancer Res"},{"key":"2022070923454508800_ref15","doi-asserted-by":"crossref","first-page":"2072","DOI":"10.1200\/JCO.19.00327","article-title":"Clofarabine can replace anthracyclines and etoposide in remission induction therapy for childhood acute myeloid leukemia: the AML08 Multicenter, randomized phase III trial","volume":"37","author":"Rubnitz","year":"2019","journal-title":"J Clin Oncol"},{"key":"2022070923454508800_ref16","doi-asserted-by":"crossref","first-page":"3021","DOI":"10.1200\/JCO.2014.55.3628","article-title":"Gemtuzumab ozogamicin in children and adolescents with de novo acute myeloid leukemia improves event-free survival by reducing relapse risk: results from the randomized phase III Children\u2019s oncology group trial AAML0531","volume":"32","author":"Gamis","year":"2014","journal-title":"J Clin Oncol"},{"key":"2022070923454508800_ref17","doi-asserted-by":"crossref","first-page":"3625","DOI":"10.1200\/JCO.2011.41.5323","article-title":"Comparative analysis of different approaches to measure treatment response in acute myeloid leukemia","volume":"30","author":"Inaba","year":"2012","journal-title":"J Clin Oncol"},{"key":"2022070923454508800_ref18","doi-asserted-by":"crossref","first-page":"366","DOI":"10.1111\/j.1365-2141.2011.08851.x","article-title":"Results of a randomized trial in children with acute myeloid leukaemia: medical research council AML12 trial","volume":"155","author":"Gibson","year":"2011","journal-title":"Br J Haematol"},{"key":"2022070923454508800_ref19","doi-asserted-by":"crossref","first-page":"37","DOI":"10.1182\/blood-2013-02-484097","article-title":"Randomized trial comparing liposomal daunorubicin with idarubicin as induction for pediatric acute myeloid leukemia: results from study AML-BFM 2004","volume":"122","author":"Creutzig","year":"2013","journal-title":"Blood"},{"key":"2022070923454508800_ref20","doi-asserted-by":"crossref","first-page":"130","DOI":"10.1046\/j.1365-2141.1998.00677.x","article-title":"Marked improvements in outcome with chemotherapy alone in paediatric acute myeloid leukemia: results of the United Kingdom Medical Research Council's 10th AML trial. MRC childhood leukaemia working party","volume":"101","author":"Stevens","year":"1998","journal-title":"Br J Haematol"},{"key":"2022070923454508800_ref21","doi-asserted-by":"crossref","first-page":"1879","DOI":"10.3324\/haematol.2019.220962","article-title":"Bortezomib with standard chemotherapy for children with acute myeloid leukemia does not improve treatment outcomes: a report from the Children's oncology group","volume":"105","author":"Aplenc","year":"2020","journal-title":"Haematologica"},{"key":"2022070923454508800_ref22","doi-asserted-by":"crossref","first-page":"361","DOI":"10.1007\/s00277-014-2218-6","article-title":"Mylotarg has potent anti-leukaemic effect: a systematic review and meta-analysis of anti-CD33 antibody treatment in acute myeloid leukaemia","volume":"94","author":"Loke","year":"2015","journal-title":"Ann Hematol"},{"key":"2022070923454508800_ref23","doi-asserted-by":"crossref","first-page":"1951","DOI":"10.1158\/1078-0432.CCR-15-1349","article-title":"Gemtuzumab Ozogamicin reduces relapse risk in FLT3\/ITD acute myeloid Leukemia: a report from the Children's oncology group","volume":"22","author":"Tarlock","year":"2016","journal-title":"Clin Cancer Res"},{"key":"2022070923454508800_ref24","doi-asserted-by":"crossref","first-page":"3149","DOI":"10.1200\/JCO.20.03048","article-title":"Gemtuzumab Ozogamicin improves event-free survival and reduces relapse in Pediatric KMT2A-rearranged AML: results from the phase III Children's oncology group trial AAML0531","volume":"39","author":"Pollard","year":"2021","journal-title":"J Clin Oncol"},{"key":"2022070923454508800_ref25","doi-asserted-by":"crossref","first-page":"587","DOI":"10.1093\/jjco\/hyy061","article-title":"Evaluation of high-dose cytarabine in induction therapy for children with de novo acute myeloid leukemia: a study protocol of the Japan Children's cancer group multi-Center seamless phase II-III randomized trial (JPLSG AML-12)","volume":"48","author":"Tomizawa","year":"2018","journal-title":"Jpn J Clin Oncol"}],"container-title":["Japanese Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/jjco\/advance-article-pdf\/doi\/10.1093\/jjco\/hyac105\/44679795\/hyac105.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jjco\/advance-article-pdf\/doi\/10.1093\/jjco\/hyac105\/44679795\/hyac105.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,7,9]],"date-time":"2022-07-09T23:46:04Z","timestamp":1657410364000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jjco\/advance-article\/doi\/10.1093\/jjco\/hyac105\/6634231"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,7,9]]},"references-count":25,"URL":"https:\/\/doi.org\/10.1093\/jjco\/hyac105","relation":{},"ISSN":["1465-3621"],"issn-type":[{"value":"1465-3621","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,7,9]]},"article-number":"hyac105"}}