{"entity":{"id":"anbl0032","kind":"trial","name":"COG ANBL0032","aka":[],"tldr":"The trial that made anti-GD2 immunotherapy standard for children with high-risk neuroblastoma, improving survival by about 20 points.","summary":"COG ANBL0032, trial NCT00026312 run by the Children's Oncology Group and published in the New England Journal of Medicine in 2010, made anti-GD2 immunotherapy standard for children with high-risk neuroblastoma, improving survival by about twenty points. It randomised 226 children after transplant to the anti-GD2 antibody ch14.18, now dinutuximab, with GM-CSF, interleukin-2 and isotretinoin, or isotretinoin alone, met its primary event-free survival endpoint at two years and improved overall survival, was stopped early for efficacy, and led to approval in 2015 with long-term follow-up confirming the gain. OnCo links it to paediatric neuroblastoma, GD2 as a target, dinutuximab, the Children's Oncology Group, Alice L. Yu, Julie R. Park and the bottleneck of paediatric cancers without markets. Whether anti-GD2 can move earlier into induction is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00026312","url":"https://clinicaltrials.gov/study/NCT00026312"}],"tags":[],"related":[],"cancers":["neuroblastoma","neuroblastoma-high-risk"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["gd2"],"drugs":["dinutuximab","isotretinoin"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["alice-yu","julie-park"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00026312","phase":"3","setting":"High-risk neuroblastoma after transplant: ch14.18 (dinutuximab) + GM-CSF + IL-2 + isotretinoin vs isotretinoin alone","sponsor":"Children's Oncology Group","result":"2-year EFS 66% vs 46%; OS 86% vs 75%.","started":"2001-10-26","startedType":"actual","yearReported":2010,"enrolled":226,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov lists 1,449 participants (actual) enrolled over the life of the study; the NEJM 2010 analysis randomised 226 eligible patients.","outcomes":[{"endpoint":"Event-free survival at 2 years","primary":true,"unit":"%","arms":[{"name":"Immunotherapy + isotretinoin","n":113,"value":66},{"name":"Isotretinoin","n":113,"value":46}],"p":"0.01","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa0911123"},{"endpoint":"Overall survival at 2 years","unit":"%","arms":[{"name":"Immunotherapy + isotretinoin","value":86},{"name":"Isotretinoin","value":75}],"p":"0.02","source":"https://doi.org/10.1056/NEJMoa0911123"}],"replication":"SIOPEN HR-NBL1 confirmed anti-GD2 benefit with dinutuximab beta (and showed IL-2 adds no efficacy)."},"route":"/trials/anbl0032/","neighbours":{"cancer":[{"id":"neuroblastoma-high-risk","kind":"cancer","name":"High-risk neuroblastoma","route":"/cancers/neuroblastoma-high-risk/"},{"id":"neuroblastoma","kind":"cancer","name":"Neuroblastoma (paediatric)","route":"/cancers/neuroblastoma/"}],"technology":[{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"gd2","kind":"target","name":"GD2 (disialoganglioside)","route":"/targets/gd2/"}],"drug":[{"id":"dinutuximab","kind":"drug","name":"Dinutuximab (ch14.18) / dinutuximab beta","route":"/drugs/dinutuximab/"},{"id":"isotretinoin","kind":"drug","name":"Isotretinoin","route":"/drugs/isotretinoin/"}],"company":[{"id":"childrens-oncology-group","kind":"company","name":"Children's Oncology Group (COG)","route":"/companies/childrens-oncology-group/"}],"person":[{"id":"alice-yu","kind":"person","name":"Alice L. Yu","route":"/people/alice-yu/"},{"id":"julie-park","kind":"person","name":"Julie R. Park","route":"/people/julie-park/"}],"bottleneck":[{"id":"b-rare-cancers","kind":"bottleneck","name":"Rare and paediatric cancers without markets","route":"/bottlenecks/b-rare-cancers/"}],"roadmap":[{"id":"paediatric-oncology-roadmap","kind":"roadmap","name":"Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first","route":"/roadmaps/paediatric-oncology-roadmap/"}]}}