{"entity":{"id":"verona","kind":"trial","name":"VERONA","aka":[],"tldr":"VERONA tested whether adding venetoclax to azacitidine, the combination that transformed treatment of acute myeloid leukaemia in older patients, would also help people with higher-risk myelodysplastic syndromes live longer; it did not meet that goal.","summary":"Venetoclax plus azacitidine became the standard for older or unfit patients with acute myeloid leukaemia after VIALE-A, and early studies suggested the pair produced high response rates in higher-risk myelodysplastic syndromes too. VERONA randomised 531 patients with untreated higher-risk myelodysplastic syndromes to azacitidine with venetoclax or placebo, with overall survival and complete remission as the primary endpoints.\n\nThe trial did not show a significant improvement in overall survival with the combination. It joins a run of failed phase 3 trials in higher-risk disease, including sabatolimab, pevonedistat and magrolimab, and leaves azacitidine alone, or transplant where possible, as the standard.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT04401748","url":"https://clinicaltrials.gov/study/NCT04401748"}],"tags":["subtype-trials"],"related":[],"cancers":["mds-higher-risk","mds"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["venetoclax","azacitidine"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["amer-zeidan"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04401748","phase":"3","setting":"Untreated higher-risk myelodysplastic syndromes: azacitidine with venetoclax or placebo","sponsor":"AbbVie","participation":[{"nct":"NCT04401748","source":"https://clinicaltrials.gov/study/NCT04401748","fetchedAt":"2026-10-07T16:53:19.341Z","studySha256":"09bf9a80f017347a5c820c98ff72debe83b0d292a21da04734ffb3495abdbf49","overallStatus":"ACTIVE_NOT_RECRUITING","lastUpdatePosted":"2026-05-06","leadSponsor":"AbbVie","collaboratorCount":1,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":531,"enrolmentType":"ACTUAL","siteCount":220,"recruitingSiteCount":0,"countries":["Australia","Austria","Belgium","Brazil","Canada","China","Czechia","France","Germany","Hungary","Israel","Italy","Japan","Netherlands","Poland","Puerto Rico","Russia","South Korea","Spain","Taiwan","Turkey (Türkiye)","United Kingdom","United States"]}],"result":"Venetoclax added to azacitidine did not significantly improve overall survival in untreated higher-risk myelodysplastic syndromes.","started":"2020-09-10","startedType":"actual","yearReported":2025,"enrolled":531,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/verona/","neighbours":{"cancer":[{"id":"mds-higher-risk","kind":"cancer","name":"Higher-risk myelodysplastic syndromes","route":"/cancers/mds-higher-risk/"},{"id":"mds","kind":"cancer","name":"Myelodysplastic syndromes / neoplasms (MDS)","route":"/cancers/mds/"}],"technology":[{"id":"bcl2-inhibitors","kind":"technology","name":"BCL-2 inhibitors","route":"/technologies/bcl2-inhibitors/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"azacitidine","kind":"drug","name":"Azacitidine","route":"/drugs/azacitidine/"},{"id":"venetoclax","kind":"drug","name":"Venetoclax","route":"/drugs/venetoclax/"}],"company":[{"id":"abbvie","kind":"company","name":"AbbVie (incl. ImmunoGen, Capstan)","route":"/companies/abbvie/"}],"person":[{"id":"amer-zeidan","kind":"person","name":"Amer M. Zeidan","route":"/people/amer-zeidan/"}]}}