New drug gilteritinib may beat standard therapy in preventing AML relapse after transplant

NCT ID NCT07463651

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

Summary

This Phase 3 trial tests whether the drug gilteritinib is better than sorafenib at keeping leukemia from coming back in patients with a specific gene mutation (FLT3-ITD) after a stem cell transplant. About 594 adults and teens will take one of the two pills daily for up to 2 years. The study uses advanced testing to detect very small amounts of cancer cells early.

What this could mean

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

Active substance

Gilteritinib and sorafenib (oral drugs)

What this could lead to

If gilteritinib works better, it could become a new standard maintenance therapy to prevent leukemia relapse after transplant.

What could go wrong

This is an early-stage Phase 3 trial with 594 participants. Results may not show a clear benefit, and both drugs have side effects like liver issues or infections.

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

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: •••••@•••••

Locations

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200025, China

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

    Contact

  • the First Affiliated Hosptital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, 215006, China

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

    Contact