New targeted therapy combo takes on tough leukemia

NCT ID NCT06034470

Ongoing Disease control Sponsor: Fred Hutchinson Cancer Center Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This early-phase trial tests a new targeted drug called pivekimab sunirine (PVEK) alongside a standard chemotherapy regimen (FLAG-Ida) in 30 adults with newly diagnosed, high-risk acute myeloid leukemia or related blood cancers. PVEK works like a smart bomb, attaching to a protein on cancer cells and delivering chemo directly to them. The main goals are to find the safest dose and see how well the combination works.

What this could mean

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

Active substance: Pivekimab sunirine (PVEK) combined with fludarabine, cytarabine, G-CSF, and idarubicin (FLAG-Ida)
What this could lead to: If it works, this could point toward a more effective treatment for aggressive acute myeloid leukemia that is hard to cure with standard chemo alone.
What could go wrong: This is a very early Phase 1 trial with only 30 people, so safety and dosing are still being figured out. The drug combo may cause severe side effects like prolonged low blood counts, and it is not yet known if it improves survival.

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 biphenotypic leukemia acute myeloid leukemia mixed phenotype acute leukemia myelodysplastic syndrome Myelodysplastic Syndromes myelodysplastic/myeloproliferative disease myelodysplastic/myeloproliferative neoplasm Myeloproliferative Disorders myeloproliferative neoplasm

As listed by the trial registrant

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

ACUTE MYELOID LEUKEMIA MIXED PHENOTYPE ACUTE LEUKEMIA MYELODYSPLASTIC SYNDROME MYELODYSPLASTIC/MYELOPROLIFERATIVE NEOPLASM MYELOPROLIFERATIVE NEOPLASM

Contacts and locations

Locations

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

More trials for these conditions

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