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

NCT05001828 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-01-21

No results posted yet for this study

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.

Conditions

  • Acute Myeloid Leukemia, Adult

Interventions

DRUG

ADI-PEG 20

ADI-PEG 20 in combination with venetoclax and azacitidine

Sponsors & Collaborators

  • Polaris Group

    lead INDUSTRY

Principal Investigators

  • John S Bomalaski, MD · Polaris Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-05
Primary Completion
2026-05-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05001828 on ClinicalTrials.gov