Trial intelligence / Profile preview

Bleximenib in Newly Diagnosed KMT2A-rearranged or NPM1-mutant AML

NCT07223814Phase 3

Key facts

Status: Recruiting
Start: Mar 2026
Primary completion: Jun 2030
Countries: 13
Sponsor: HOVON
Modality: Small Molecules

Drugs: bleximenib
Conditions: acute myeloid leukemia (AML)

Overview

Phase 3, randomised, double-blind trial of bleximenib in acute myeloid leukemia (AML) (3 arms), sponsored by HOVON. Primary endpoint: Event-Free Survival. Started Mar 2026; status: recruiting.

Design

3 arms

Study design: RandomizedDouble-blind

Arm 1: Standard of care + bleximenib + bleximenib maintenance
Bleximenib in combination with remission induction and consolidation therapy, followed by bleximenib maintenance therapy.
Arm 2: Standard of care + bleximenib + placebo maintenance
Bleximenib in combination with remission induction and consolidation therapy, followed by placebo maintenance therapy.
Arm 3: Standard of care + placebo + placebo maintenance
Placebo comparator in combination with remission induction and consolidation therapy, followed by placebo maintenance therapy.

Who it enrols

Adults with newly diagnosed, previously untreated AML with NPM1 mutation or KMT2A rearrangement, eligible for intensive chemotherapy, with adequate organ function and no severe cardiac or respiratory disease.

Endpoints

Primary

Event-Free SurvivalUp to 4 years and 5 months

Secondary

Overall SurvivalUp to 7 years and 10 months
Rates of Complete Remission (CR, CRh, CRi)Up to 7 years and 10 months
Duration of Complete RemissionUp to 4 years and 5 months
Percentage of participants undergoing an allo-SCTUp to 7 years and 10 months

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