# VERONA

Source: https://onco.cc/trials/verona/  
OnCo record `verona` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

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.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-17
- Tags: subtype-trials
- Registry id: NCT04401748
- Phase: 3
- Setting: Untreated higher-risk myelodysplastic syndromes: azacitidine with venetoclax or placebo
- Sponsor: AbbVie
- Enrolled: 531
- Result: Venetoclax added to azacitidine did not significantly improve overall survival in untreated higher-risk myelodysplastic syndromes.

## Sources

- ClinicalTrials.gov NCT04401748: https://clinicaltrials.gov/study/NCT04401748

## Connected records

- cancers: [Higher-risk myelodysplastic syndromes](https://onco.cc/cancers/mds-higher-risk/), [Myelodysplastic syndromes / neoplasms (MDS)](https://onco.cc/cancers/mds/)
- drugs: [Azacitidine](https://onco.cc/drugs/azacitidine/), [Venetoclax](https://onco.cc/drugs/venetoclax/)
- companies: [AbbVie (incl. ImmunoGen, Capstan)](https://onco.cc/companies/abbvie/)
- people: [Amer M. Zeidan](https://onco.cc/people/amer-zeidan/)

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JSON: https://onco.cc/api/v1/entities/verona.json