{"entity":{"id":"aall1731","kind":"trial","name":"COG AALL1731","aka":[],"tldr":"In children with average-risk leukaemia, adding blinatumomab pushed three-year disease-free survival from 88% to 96%, one of the largest gains in decades.","summary":"1,440 randomised children with standard-risk average or high subsets. 3-year DFS 96.0% vs 87.9% (HR 0.39, 95% CI 0.24-0.64); randomisation stopped early for efficacy. NEJM 2024. Led to FDA approval of blinatumomab in the consolidation phase for CD19+ Ph-negative B-ALL in children (June 2024) and is being adopted as the new paediatric standard.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03914625","url":"https://clinicaltrials.gov/study/NCT03914625"},{"label":"NEJM 2024","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2411680"}],"tags":[],"related":[],"cancers":["all-leukemia","all-paediatric-standard-risk"],"sections":[],"technologies":["t-cell-engager"],"targets":["cd19","cd3"],"drugs":["blinatumomab","crisantaspase"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["stephen-hunger","sumit-gupta","rachel-rau"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03914625","phase":"3","setting":"Newly diagnosed standard-risk B-ALL in children: two cycles of blinatumomab added to chemotherapy vs chemotherapy alone","sponsor":"Children's Oncology Group / NCI","result":"3-year DFS 96.0% vs 87.9%; HR 0.39.","started":"2019-07-03","startedType":"actual","yearReported":2024,"enrolled":1440,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov lists an estimated 6,720 participants for the whole trial, which enrols all standard-risk patients; the NEJM 2024 interim analysis covered the 1,440 patients randomised (722 chemotherapy, 718 blinatumomab) before randomisation was stopped.","outcomes":[{"endpoint":"Disease-free survival at 3 years","primary":true,"unit":"%","arms":[{"name":"Blinatumomab + chemotherapy","n":722,"value":96},{"name":"Chemotherapy","n":718,"value":87.9}],"hr":0.39,"ci":[0.24,0.64],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2411680"}],"replication":"Consistent with E1910 in adults; the paediatric MRD-positive blinatumomab trials (AALL1331, IntReALL HR 2010) had shown benefit in relapse earlier."},"route":"/trials/aall1731/","neighbours":{"cancer":[{"id":"all-leukemia","kind":"cancer","name":"Acute lymphoblastic leukaemia","route":"/cancers/all-leukemia/"},{"id":"all-paediatric-standard-risk","kind":"cancer","name":"Standard-risk B-cell acute lymphoblastic leukaemia in children","route":"/cancers/all-paediatric-standard-risk/"}],"technology":[{"id":"t-cell-engager","kind":"technology","name":"T-cell engagers (bispecific)","route":"/technologies/t-cell-engager/"}],"target":[{"id":"cd19","kind":"target","name":"CD19","route":"/targets/cd19/"},{"id":"cd3","kind":"target","name":"CD3","route":"/targets/cd3/"}],"drug":[{"id":"blinatumomab","kind":"drug","name":"Blinatumomab","route":"/drugs/blinatumomab/"},{"id":"crisantaspase","kind":"drug","name":"Crisantaspase (recombinant Erwinia asparaginase)","route":"/drugs/crisantaspase/"}],"company":[{"id":"childrens-oncology-group","kind":"company","name":"Children's Oncology Group (COG)","route":"/companies/childrens-oncology-group/"}],"person":[{"id":"rachel-rau","kind":"person","name":"Rachel E. Rau","route":"/people/rachel-rau/"},{"id":"stephen-hunger","kind":"person","name":"Stephen P. Hunger","route":"/people/stephen-hunger/"},{"id":"sumit-gupta","kind":"person","name":"Sumit Gupta","route":"/people/sumit-gupta/"}],"pairing":[{"id":"blinatumomab-frontline-consolidation","kind":"pairing","name":"Blinatumomab added to frontline chemotherapy","route":"/pairings/blinatumomab-frontline-consolidation/"}],"bottleneck":[{"id":"b-rare-cancers","kind":"bottleneck","name":"Rare and paediatric cancers without markets","route":"/bottlenecks/b-rare-cancers/"}],"paper":[{"id":"paper-aall1731-blinatumomab-children-nejm-2025","kind":"paper","name":"Children's Oncology Group AALL1731: blinatumomab added to chemotherapy for children with standard-risk B-cell ALL","route":"/key-papers/paper-aall1731-blinatumomab-children-nejm-2025/"}],"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/"}]}}