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

StatusActive, Not Recruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 7 months later May 2026 → Jan 2027
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Record History

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  1. Primary completion pushed from May 2026 to Jan 2027
    • Study completion date: Dec 2026 to Jan 2027
    • Eligibility criteria expanded, about 14 words
    • Study description revised
  2. Primary completion date: Dec 2025 to May 2026
    • Study completion date: Jul 2026 to Dec 2026
    v8
  3. Trial status: Recruiting to Active, Not Recruitingv7 Show 4 more changesShow less
    • Enrollment target: estimated 60 to confirmed 38
    • Study sites: 4 to 3
    • Primary completion date: Jul 2025 to Dec 2025
    • Study completion date: Dec 2025 to Jul 2026
  4. Study sites: 3 to 4
    • Eligibility criteria revised
    • Study description expanded, about 6 words
    v6
  5. Study sites: 1 to 3
    • Eligibility criteria expanded, about 46 words
    v5
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  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2022 to Apr 5, 2022
    • Site details revised
    v4
  2. Primary completion date: Aug 2022 to Jul 2025
    • Start date: Aug 2021 to Apr 2022
    • Study completion date: Feb 2023 to Dec 2025
    v3
  3. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05001828
Lead Sponsor Polaris Group
Conditions
(from sponsor)		 Acute Myeloid Leukemia, Adult
Related terms Leukemia, Myeloid, Acute
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov