Ivosidenib and Azacitidine With or Without Venetoclax in Adult Patients With Newly Diagnosed IDH1-Mutated AML or MDS/AML Considered Ineligible for Intensive Chemotherapy (EVOLVE-1)

Research summary

The proposed trial test whether the addition of venetoclax,compared to placebo,with azacitidine and ivosidenib improves outcomes in newly diagnosed adult patients with IDH1 mutated AML,who are not considered candidates for intensive chemotherapy by measuring event free survival.. Newly diagnosed,previously untreated patients ≥18 years of age with IDH1-mutated or IDH1 mutated MDS/AML that are eligible for the study will be randomised in a 1:1 ratio to therapy with ivosidenib /azacitidine with venetoclax 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 12 months after randomization of the last IDH1-mutated AML patient. There will be an observational follow-up regarding survival and subsequent therapy of 5 years after randomisation of the last patient. Approximately 227 patients (of which a minimum of 204 with IDH1 -mutated AML) will be recruited.

Principal Investigator

Prof Paresh Vyas

Contact us

Email: Latephasehaematology@ouh.nhs.uk

IRAS number

1011419