{"entity":{"id":"advl0912-crizotinib","kind":"trial","name":"COG ADVL0912: crizotinib in children with ALK-driven tumours","aka":["ADVL0912","Crizotinib in paediatric anaplastic large cell lymphoma","Mossé 2017"],"tldr":"A lung cancer drug that blocks ALK made relapsed ALK-positive lymphoma disappear on scans in most of the children who took it.","summary":"Fusions of the ALK gene drive most paediatric anaplastic large cell lymphomas and inflammatory myofibroblastic tumours. This Children's Oncology Group phase 1/2 study gave crizotinib, the ALK inhibitor developed for lung cancer, to children with relapsed or refractory solid tumours or ALCL; the registry records 122 participants across all its cohorts. The 2017 report covers 26 patients with relapsed or refractory ALK-positive ALCL and 14 with metastatic or inoperable ALK-positive inflammatory myofibroblastic tumour.\n\nIn ALCL the overall response was 83 per cent at 165 mg/m2 and 90 per cent at 280 mg/m2, with complete responses in five of six and 16 of 20. The median duration of therapy was 2.79 and 0.4 years, and 12 patients stopped protocol therapy to proceed to transplant. The commonest drug-related adverse event was a fall in the neutrophil count, in 33 and 70 per cent of the two ALCL dose groups. Levels of the NPM-ALK fusion transcript in the blood fell during treatment in most patients with ALCL.","status":"positive","asOf":"2026-11-03","links":[{"label":"ClinicalTrials.gov NCT00939770","url":"https://clinicaltrials.gov/study/NCT00939770"},{"label":"Journal of Clinical Oncology 2017","url":"https://doi.org/10.1200/JCO.2017.73.4830"}],"tags":["lymphoma-evidence-entities"],"related":[],"cancers":["alk-positive-anaplastic-large-cell-lymphoma","inflammatory-myofibroblastic-tumour","peripheral-t-cell-lymphoma"],"sections":["targeted-therapy"],"technologies":["kinase-inhibitors"],"targets":["alk"],"drugs":["crizotinib"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":["orr","complete-response"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-crizotinib-paediatric-alcl-imt-jco-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00939770","phase":"1/2","setting":"Children and young people with relapsed or refractory solid tumours or anaplastic large cell lymphoma; the reported cohorts were relapsed ALK-positive ALCL and metastatic or inoperable ALK-positive inflammatory myofibroblastic tumour, given crizotinib by mouth twice daily","sponsor":"Children's Oncology Group","result":"In relapsed ALK-positive ALCL, overall response 83 and 90 per cent at the two doses, with complete responses in 21 of 26.","started":"2009-09-21","startedType":"actual","yearReported":2017,"enrolled":122,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall response rate, ALK-positive ALCL","primary":true,"unit":"%","arms":[{"name":"Crizotinib 165 mg/m2","n":6,"value":83},{"name":"Crizotinib 280 mg/m2","n":20,"value":90}],"source":"https://doi.org/10.1200/JCO.2017.73.4830"},{"endpoint":"Overall response rate, ALK-positive inflammatory myofibroblastic tumour","unit":"%","arms":[{"name":"Crizotinib 100 to 280 mg/m2","n":14,"value":86}],"source":"https://doi.org/10.1200/JCO.2017.73.4830"}],"replication":"Single-arm; no randomised comparison in ALCL."},"route":"/trials/advl0912-crizotinib/","neighbours":{"cancer":[{"id":"alk-positive-anaplastic-large-cell-lymphoma","kind":"cancer","name":"ALK-positive anaplastic large cell lymphoma","route":"/cancers/alk-positive-anaplastic-large-cell-lymphoma/"},{"id":"inflammatory-myofibroblastic-tumour","kind":"cancer","name":"Inflammatory myofibroblastic tumour (IMT)","route":"/cancers/inflammatory-myofibroblastic-tumour/"},{"id":"peripheral-t-cell-lymphoma","kind":"cancer","name":"Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma)","route":"/cancers/peripheral-t-cell-lymphoma/"}],"section":[{"id":"targeted-therapy","kind":"section","name":"Targeted Therapy","route":"/fronts/targeted-therapy/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"alk","kind":"target","name":"ALK","route":"/targets/alk/"}],"drug":[{"id":"crizotinib","kind":"drug","name":"Crizotinib","route":"/drugs/crizotinib/"}],"company":[{"id":"childrens-oncology-group","kind":"company","name":"Children's Oncology Group (COG)","route":"/companies/childrens-oncology-group/"}],"term":[{"id":"complete-response","kind":"term","name":"Complete response","route":"/terms/complete-response/"},{"id":"orr","kind":"term","name":"Objective response rate (ORR)","route":"/terms/orr/"}],"paper":[{"id":"paper-crizotinib-paediatric-alcl-imt-jco-2017","kind":"paper","name":"Targeting ALK With Crizotinib in Pediatric Anaplastic Large Cell Lymphoma and Inflammatory Myofibroblastic Tumor: A Children's Oncology Group Study","route":"/key-papers/paper-crizotinib-paediatric-alcl-imt-jco-2017/"}]}}