Sponsor: Oncoverity, Inc
Sponsor Study ID: OV-AML-1231
Study Title: A Multicenter, Open Label, Randomized, Phase 2 Study of Venetoclax and Azacitidine Plus Cusatuzumab Versus Venetoclax and Azacitidine Alone in Newly Diagnosed AML Patients who are not Candidates for Intensive Therapy
CTO #: 104022
NCT Number: NCT06384261
Phase: II
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Myeloid and Monocytic Leukemia
Study Objectives: To determine the efficacy of adding cusatuzumab to venetoclax plus azacitidine (VAC) compared to venetoclax plus azacitidine (VA) alone. To determine the efficacy of adding cusatuzumab to VA compared to VA alone. To determine the efficacy of VAC compared to VA in the adverse, intermediate, and favorable subgroups of participants defined by a newly developed CU VA specific risk stratification model, the ELN 2022 risk model and the risk model published in Bataller et al.