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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.
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.
The 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.
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares BCL-2 inhibitors, AbbVie (incl. ImmunoGen, Capstan), Venetoclax, Small-molecule kinase inhibitors and the tag subtype-trials.
Shares Higher-risk myelodysplastic syndromes, Azacitidine, Myelodysplastic syndromes / neoplasms (MDS) and the tag subtype-trials.
Shares AbbVie (incl. ImmunoGen, Capstan), Small-molecule kinase inhibitors and the tag subtype-trials.
Shares AbbVie (incl. ImmunoGen, Capstan) and the tag subtype-trials.
Shares AbbVie (incl. ImmunoGen, Capstan) and the tag subtype-trials.
Shares Myelodysplastic syndromes / neoplasms (MDS) and the tag subtype-trials.
Shares Myelodysplastic syndromes / neoplasms (MDS) and the tag subtype-trials.
Shares Myelodysplastic syndromes / neoplasms (MDS) and the tag subtype-trials.
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