{"entity":{"id":"cpx-351-301","kind":"trial","name":"CPX-351 Study 301","aka":[],"tldr":"Repackaging two old chemotherapies into liposomes doubled five-year survival in older adults with the worst kinds of AML.","summary":"CPX-351 Study 301, trial NCT01696084 sponsored by Celator, now Jazz, and published in JCO in 2018 with a five-year update in Lancet Haematology in 2021, showed that repackaging daunorubicin and cytarabine into liposomes doubled five-year survival in adults aged 60 to 75 with newly diagnosed high-risk or secondary acute myeloid leukaemia. It randomised 309 patients to CPX-351 or conventional 7+3 chemotherapy, met its primary overall survival endpoint, raised the remission rate, and more patients reached transplant with longer survival afterwards. OnCo links it to acute myeloid leukaemia, the CPX-351 record and the 7+3 regimen. There is no second randomised trial, although the UK NCRI AML19 trial and real-world registries report comparable remission rates in secondary disease, and whether the benefit holds in younger patients or against venetoclax-based regimens is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01696084","url":"https://clinicaltrials.gov/study/NCT01696084"}],"tags":[],"related":[],"cancers":["aml","aml-secondary"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["cpx-351","cytarabine-7-3"],"companies":["jazz"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01696084","phase":"3","setting":"Newly diagnosed high-risk or secondary AML, age 60-75: CPX-351 vs conventional 7+3","sponsor":"Celator / Jazz","result":"OS 9.56 vs 5.95 months, HR 0.69; 5-year OS 18% vs 8%.","started":"2012-12-13","startedType":"actual","yearReported":2018,"enrolled":309,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"CPX-351","n":153,"value":9.56},{"name":"7+3","n":156,"value":5.95}],"hr":0.69,"ci":[0.52,0.9],"p":"0.003","source":"https://ascopubs.org/doi/10.1200/JCO.2017.77.6112"},{"endpoint":"5-year overall survival","unit":"%","arms":[{"name":"CPX-351","value":18},{"name":"7+3","value":8}],"source":"https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(21)00134-4/abstract"}],"replication":"No second randomised trial; UK NCRI AML19 and real-world registries report comparable remission rates in secondary AML."},"route":"/trials/cpx-351-301/","neighbours":{"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"},{"id":"aml-secondary","kind":"cancer","name":"Secondary and therapy-related acute myeloid leukaemia","route":"/cancers/aml-secondary/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"cpx-351","kind":"drug","name":"CPX-351 (liposomal daunorubicin-cytarabine)","route":"/drugs/cpx-351/"},{"id":"cytarabine-7-3","kind":"drug","name":"Cytarabine + anthracycline ('7+3')","route":"/drugs/cytarabine-7-3/"}],"company":[{"id":"jazz","kind":"company","name":"Jazz Pharmaceuticals","route":"/companies/jazz/"}]}}