New hope for kids with tough leukemia: targeted drug combo enters first human trial

NCT ID NCT06376162

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests a new drug called ziftomenib, taken as a capsule, together with standard chemotherapy (cytarabine and fludarabine) for children and young adults up to age 21 who have a relapsed or refractory acute leukemia with specific genetic changes (KMT2A-r, NUP98-r, or NPM1-m). The main goal is to find the safest dose and understand how the drug behaves in the body. Only 20 participants will be enrolled, and the study is currently recruiting.

What this could mean

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

Active substance

ziftomenib (a menin inhibitor) combined with chemotherapy (cytarabine and fludarabine)

What this could lead to

If successful, this could point toward a new treatment option for children with hard-to-treat leukemia that has come back or not responded to standard therapy.

What could go wrong

This is a very early phase 1 trial with only 20 participants, so safety and dosing are still being figured out. It may not work or could cause serious side effects.

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 myeloid leukemia with mutated NPM1 acute myeloid leukemia, MLL gene rearrangement Recurrence

As listed by the trial registrant

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

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

  • CHU de Nantes - Hôpital Femme-Enfant-Adolescent

    RECRUITING

    Nantes, Loire-Atlantique, 44093, France

  • CHU de Reims - Hôpital Robert Debré

    RECRUITING

    Paris, Île-de-France Region, 75019, France

  • Children's Healthcare of Atlanta

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital Los Angeles

    RECRUITING

    Los Angeles, California, 90027, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229-3026, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Fondazione IRCCS San Gerardo dei Tintori (Ospedale San Gerardo)

    RECRUITING

    Monza, 20900, Italy

  • Hospital Infantil Universitario Niño Jesús

    RECRUITING

    Madrid, 28009, Spain

  • Hospital Universitari Vall d'Hebrón

    RECRUITING

    Barcelona, 08035, Spain

  • Memorial Sloan Kettering Cancer Center - New York

    RECRUITING

    New York, New York, 10065, United States

  • Ospedale Pediatrico Bambino Gesù

    RECRUITING

    Roma, Rome, 00165, Italy

  • Prinses Maxima Centrum Kinderoncologie

    RECRUITING

    Utrecht, 3584 CS, Netherlands

  • Sankt Anna-Kinderspital

    RECRUITING

    Vienna, State of Vienna, 1090, Austria

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

  • SickKids - The Hospital for Sick Children

    RECRUITING

    Toronto, Ontario, M5G 1X8, Canada

  • St. Jude Children's Research Hospital

    RECRUITING

    Memphis, Tennessee, 38105-3678, United States

  • Texas Children's Hospital

    RECRUITING

    Houston, Texas, 77030, United States