New triple therapy targets FLT3-Mutated leukemia in frail patients

NCT ID NCT05520567

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

Summary

This study tests a combination of three drugs—gilteritinib, venetoclax, and azacitidine—in people newly diagnosed with a fast-growing form of acute myeloid leukemia (AML) that has a FLT3 gene change. Participants are older or have other health issues that prevent them from receiving standard intensive chemotherapy. The trial has two phases: first, finding the right dose of venetoclax, and then testing that dose in more patients to see how well it works and what side effects occur.

What this could mean

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

Active substance

gilteritinib, venetoclax, and azacitidine

What this could lead to

If successful, this combination could offer a new, less intensive treatment option for older or frail patients with FLT3-mutated AML, potentially improving remission rates.

What could go wrong

This is an early-phase trial with a small number of participants, so the benefits and risks are not yet fully known. Side effects from the drug combination could be serious, and the treatment may not work for everyone.

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 acute myeloid leukemia, FLT3 internal tandem duplication neoplasm

As listed by the trial registrant

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

Contacts and locations

Locations

  • City of Hope Nat'l Medical Center

    Duarte, California, 91010, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Memorial Cancer Institute

    Pembroke Pines, Florida, 33028, United States

  • Motefiore-Einstein Center for Cancer Care

    The Bronx, New York, 10461, United States

  • Novant Health

    Winston-Salem, North Carolina, 27103, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Robert H. Lurie Comprehensive Cancer Center

    Chicago, Illinois, 61612, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • Sarah Cannon Research Institute

    Denver, Colorado, 80218, United States

  • The Medical College of Wisconsin- Froedtert Hospital

    Milwaukee, Wisconsin, 53226, United States

  • The University of Texas MD

    Houston, Texas, 77030, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • UCLA Medical Center

    Los Angeles, California, 90095, United States

  • Univ. of California - Irvine

    Irvine, California, 92697, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • University of Pennsylvania-Abramson CCC-Dept. of Hem Onc

    Philadelphia, Pennsylvania, 19104, United States

  • Weill Cornell Medical College

    New York, New York, 10065, United States