New targeted therapy combo takes on tough leukemia

NCT ID NCT06034470

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

Contacts and locations

Locations

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109, United States