Experimental combo targets leukemia by starving cancer cells

NCT ID NCT05001828

Ongoing Disease control Sponsor: Polaris Group Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests a new drug called ADI-PEG 20 added to two standard chemotherapy drugs (venetoclax and azacitidine) for people with acute myeloid leukemia (AML). The study includes 38 adults with either relapsed/refractory AML or newly diagnosed AML who cannot have intensive chemo. The main goal is to find the safest dose and look for early signs that the combination shrinks tumors.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: ADI-PEG 20 (a drug that breaks down arginine, an amino acid cancer cells need) combined with venetoclax and azacitidine (standard chemotherapy drugs)
What this could lead to: If it works, this could improve treatment options for people with acute myeloid leukemia, especially those who cannot tolerate intensive chemotherapy.
What could go wrong: This is a very early, small Phase 1 trial focused on safety and dosing, not proof of effectiveness. The combination may cause side effects or fail to show benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ACUTE MYELOID LEUKEMIA, ADULT

Contacts and locations

Locations

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States
MD Anderson Cancer Center

Houston, Texas, 77030, United States
Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

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