{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,20]],"date-time":"2026-03-20T19:56:16Z","timestamp":1774036576601,"version":"3.50.1"},"reference-count":12,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2024,3,19]],"date-time":"2024-03-19T00:00:00Z","timestamp":1710806400000},"content-version":"unspecified","delay-in-days":18,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100009619","name":"Japan Agency for Medical Research and Development","doi-asserted-by":"publisher","award":["20ck0106635h0001"],"award-info":[{"award-number":["20ck0106635h0001"]}],"id":[{"id":"10.13039\/100009619","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,3,4]]},"published-print":{"date-parts":[[2024,3]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Children and adolescents with mature B cell non-Hodgkin lymphoma (B-NHL) are treated with short-intensive chemotherapy. The burden of short-term and long-term toxicity is highly relative to its high cure rate in good-risk patients. Although the addition of rituximab to standard lymphome Malin B (LMB) chemotherapy markedly prolongs event-free survival and overall survival in high-risk patients, the benefit of rituximab in good-risk patients remains to be elucidated. This clinical trial will examine whether the addition of rituximab eliminates anthracyclines in good-risk patients without compromising treatment outcomes.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>We will perform a single-arm, open-label, multicentre phase II study. Low-risk (stage I \u2013 completely resected, stage II abdominal) and intermediate-risk (stages I and II \u2013 incompletely resected; stage II \u2013 resected, other than abdominal; stage III with LDH &lt;2\u00d7 upper limit of normal) patients with newly diagnosed B-NHL are eligible. Low-risk patients receive two courses of R-COM<jats:sub>1<\/jats:sub>P (rituximab, cyclophosphamide, vincristine, methotrexate, prednisolone and intrathecal methotrexate with hydrocortisone), and intermediate-risk patients receive COP (cyclophosphamide, vincristine, prednisolone and intrathecal methotrexate with hydrocortisone) followed by two courses each of R-COM<jats:sub>3<\/jats:sub>P and R-CYM (rituximab, cytarabine, methotrexate and intrathecal methotrexate with hydrocortisone). The primary endpoint is a 3-year event-free survival rate in paediatric patients (&lt;18 years) with intermediate-risk disease. 100 patients (10 low-risk and 90 intermediate-risk) will enrol within a 4-year enrolment period and the follow-up period will be 3 years. 108 institutions are participating as of 1 January 2024 (64 university hospitals, 29 general hospitals, 12 children\u2019s hospitals and three cancer centres).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>This research was approved by the Certified Review Board at NHO Nagoya Medical Center (Nagoya, Japan) on 21 September 2021. Written informed consent is obtained from all patients and\/or their guardians. The results of this study will be disseminated through peer-reviewed publications and conference presentations.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Study registration<\/jats:title>\n                  <jats:p>Japan Registry of Clinical Trials, jRCTs041210104.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-080762","type":"journal-article","created":{"date-parts":[[2024,3,19]],"date-time":"2024-03-19T23:45:57Z","timestamp":1710891957000},"page":"e080762","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":4,"title":["Rituximab-combined anthracycline-free chemotherapy in newly diagnosed paediatric and adolescent patients with non-high-risk aggressive mature B cell lymphoma: protocol for a single-arm, open-label, multicentre, phase II study (the Japan Children\u2019s Cancer Group Multicentre Trial, JPLSG B-NHL-20)"],"prefix":"10.1136","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9438-2673","authenticated-orcid":false,"given":"Masahiro","family":"Sekimizu","sequence":"first","affiliation":[{"name":"Department of Pediatrics, NHO Nagoya Medical Center, Nagoya, Japan"},{"name":"NHO Nagoya Medical Center, Nagoya, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Reiji","family":"Fukano","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuhki","family":"Koga","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Kyushu University, Fukuoka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tetsuo","family":"Mitsui","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Yamagata University Hospital, Yamagata, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naoto","family":"Fujita","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Hiroshima Red Cross Hospital and Atomic bomb Survivors Hospital, Hiroshima, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takeshi","family":"Mori","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology, Hyogo Prefectural Kobe Children\u2019s Hospital, Hyogo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daiki","family":"Hori","sequence":"additional","affiliation":[{"name":"Department of Hematology\/Oncology for Children and Adolescents, Sapporo Hokuyu Hospital, Sapporo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Makito","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Fujita Health University School of Medicine, Toyoake, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"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":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hideto","family":"Iwafuchi","sequence":"additional","affiliation":[{"name":"Department of Pathology, Shizuoka Children's Hospital, Shizuoka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Atsuko","family":"Nakazawa","sequence":"additional","affiliation":[{"name":"Department of Clinical Research, Saitama Children\u2019s Medical Center, Saitama, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tetsuya","family":"Mori","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, St Marianna University School of Medicine, Kawasaki, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ryoji","family":"Kobayashi","sequence":"additional","affiliation":[{"name":"Department of Hematology\/Oncology for Children and Adolescents, Sapporo Hokuyu Hospital, Sapporo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1865-4953","authenticated-orcid":false,"given":"Hiroya","family":"Hashimoto","sequence":"additional","affiliation":[{"name":"Clinical Research Center, NHO Nagoya Medical Center, Nagoya, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akiko","family":"M. 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