What type of study is this?

This is a Pre-Registered Trial study.

What question did this study set out to answer?

To evaluate the safety and efficacy of enzomenib in combination with venetoclax and azacitidine in relapsed or refractory AML.

December 8, 2025BloodOpen Access

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To evaluate the safety and efficacy of enzomenib in combination with venetoclax and azacitidine in relapsed or refractory AML.
Phase 1 study design
Enrolled adult patients with relapsed or refractory KMT2Ar or NPM1m AML
Assessed varying doses of enzomenib alongside standard therapies venetoclax and azacitidine
Primary endpoints included safety, tolerability, and recommended phase 2 dose determination.
Eighteen patients enrolled with a median age of 50 years
No dose-limiting toxicities observed across trial doses
Overall response rate was 83%, with a composite CR rate of 56%
100% of patients with no prior exposure to venetoclax achieved an objective response.

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Phase 1 study shows combination therapy improves outcomes in AML, indicating a potential new treatment approach.

Watts et al. (2025) studied this question.

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