Randomized study to assess revumenib in combination with azacitidine + venetoclax in adult patients with newly diagnosed NPM1-mutated or KMT2A-rearranged AML ineligible for intensive chemotherapy (EVOLVE 2)

Research summary

The proposed trial tests whether the addition of revumenib,compared to placebo,to azacitidine/venetoclax improves outcome in newly diagnosed adult patients with NPM1-mutated AML,who are not considered candidates for intensive chemotherapy by measuring overall survival. Newly diagnosed,previously untreated patients ≥18 years of age with NPM1-mutated or KMT2A-rearranged AML that are eligible for the study will be randomised in a 1:1 ratio to therapy with azacitidine/venetoclax with revumenib or placebo. Treatment will be on a continuous 28-day cycle schedule and continued until disease progression,development of unacceptable toxicity,death,withdrawal by subject or other protocol defined criteria for discontinuation (whichever comes first). Expected follow-up time regarding the primary endpoint is 30 months after randomisation of the last NPM1-mutated AML patient. There will be an observational follow-up regarding subsequent therapies,disease status and survival of 4 years after randomisation of the last patient. Approximately 415 patients (of which a minimum of 400 with NPM1 mutation) will be recruited.

Principal Investigator

Prof Paresh Vyas

Contact us

Email: Latephasehaematology@ouh.nhs.uk

IRAS number

1011582