{"entity":{"id":"interfant-06","kind":"trial","name":"Interfant-06","aka":[],"tldr":"The largest infant leukaemia trial showed that intensifying chemotherapy did not help, and set the stage for adding blinatumomab instead.","summary":"651 infants; 6-year EFS 46.1% overall, no benefit from myeloid-style intensification; KMT2A rearrangement (in ~75%) remained the dominant adverse factor. JCO 2019. The follow-on Interfant-21 adds blinatumomab after a pilot (NEJM 2023) showed 2-year DFS 81.6% vs 49.4% historical, and menin inhibitors are entering infant ALL trials.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00550992","url":"https://clinicaltrials.gov/study/NCT00550992"}],"tags":[],"related":[],"cancers":["all-leukemia","all-infant"],"sections":[],"technologies":["t-cell-engager"],"targets":["kmt2a"],"drugs":["blinatumomab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00550992","phase":"3","setting":"Infant ALL (<1 year): standard vs AML-type early intensification; transplant for high-risk KMT2A-rearranged infants","sponsor":"Interfant consortium","result":"6-year EFS 46.1%; intensification no benefit.","started":"2006-01","startedType":"actual","yearReported":2019,"enrolled":651,"enrolledBasis":"registered","enrolledNote":"ClinicalTrials.gov lists an estimated 445 participants and the record's status is unknown, meaning the sponsor has not verified it recently; the JCO 2019 paper reports 651 infants included.","outcomes":[{"endpoint":"Event-free survival at 6 years","primary":true,"unit":"%","arms":[{"name":"All infants","n":651,"value":46.1}],"source":"https://ascopubs.org/doi/10.1200/JCO.19.00261"}],"replication":"COG AALL0631 reported similar EFS, confirming a plateau for chemotherapy-only approaches in infant ALL."},"route":"/trials/interfant-06/","neighbours":{"cancer":[{"id":"all-leukemia","kind":"cancer","name":"Acute lymphoblastic leukaemia","route":"/cancers/all-leukemia/"},{"id":"all-infant","kind":"cancer","name":"Infant acute lymphoblastic leukaemia (KMT2A-rearranged, under one year)","route":"/cancers/all-infant/"}],"technology":[{"id":"t-cell-engager","kind":"technology","name":"T-cell engagers (bispecific)","route":"/technologies/t-cell-engager/"}],"target":[{"id":"kmt2a","kind":"target","name":"KMT2A (MLL) rearrangement","route":"/targets/kmt2a/"}],"drug":[{"id":"blinatumomab","kind":"drug","name":"Blinatumomab","route":"/drugs/blinatumomab/"}],"idea":[{"id":"idea-menin-infant-all","kind":"idea","name":"Menin inhibitors for infant KMT2A-rearranged ALL","route":"/ideas/idea-menin-infant-all/"}],"bottleneck":[{"id":"b-rare-cancers","kind":"bottleneck","name":"Rare and paediatric cancers without markets","route":"/bottlenecks/b-rare-cancers/"}],"paper":[{"id":"paper-interfant-06-pieters-jco-2019","kind":"paper","name":"Interfant-06: outcome of infants under one year with acute lymphoblastic leukaemia","route":"/key-papers/paper-interfant-06-pieters-jco-2019/"}],"institution":[{"id":"siop-europe","kind":"institution","name":"SIOP Europe (European Society for Paediatric Oncology)","route":"/institutions/siop-europe/"}],"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/"}]}}