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New drug combo aims to keep childhood leukemia at bay after transplant

NCT ID NCT07012044

Recruiting now Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 8 times

Summary

This phase 1 trial tests the safety and best dose of an oral drug called ASTX727 (a combination of cedazuridine and decitabine) along with filgrastim in children with high-risk acute myeloid leukemia (AML) that has returned or not responded to treatment. All participants have already received a stem cell transplant. The goal is to see if this maintenance therapy can help prevent the leukemia from coming back without causing severe side effects.

What this could mean

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

Active substance
ASTX727 (cedazuridine and decitabine) and filgrastim
What this could lead to
If it works, this could provide a safer maintenance option after stem cell transplant to help prevent leukemia relapse in children.
What could go wrong
This is an early phase 1 trial with only 47 participants, so safety and dosing are still being determined. It may not work or could cause serious side effects like graft-versus-host disease.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia therapy related acute myeloid leukemia and myelodysplastic syndrome

As listed by the trial registrant

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

ACUTE MYELOID LEUKEMIA POST CYTOTOXIC THERAPY RECURRENT ACUTE MYELOID LEUKEMIA REFRACTORY ACUTE MYELOID LEUKEMIA

Contacts and locations

Locations

  • C S Mott Children's Hospital

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Children's Hospital of Alabama

    RECRUITING

    Birmingham, Alabama, 35233, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Pittsburgh of UPMC

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

    Contact Email: •••••@•••••

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Riley Hospital for Children

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Saint Jude Children's Research Hospital

    RECRUITING

    Memphis, Tennessee, 38105, United States

    Contact Email: •••••@•••••

  • University of Minnesota/Masonic Cancer Center

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

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