drugset / Trial / NCT05001828

Study of ADI-PEG 20, Venetoclax and Azacitidine in Acute Myeloid Leukemia

NCT05001828

Phase 1 Active not recruiting 38 enrolled Polaris Group
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Pegylated arginine deiminase (ADI-PEG 20) will be combined with venetoclax and azacitidine for treatment of subjects with previously treated or untreated with high risk factor acute myeloid leukemia (AML). Venetoclax and azacitidine are front-line therapy for such patients, and ADI-PEG 20 will be added to this regimen in a phase IA/B study.

Timeline

Start
2022-04-05
Primary completion
2026-05
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegargiminase Protein / enzyme biologic
Background Azacitidine Other / unclassified
Background Venetoclax Small molecule