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

NCT ID NCT07463651

Recruiting now Disease control Sponsor: The First Affiliated Hospital of Soochow University Source: ClinicalTrials.gov ↗

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for ACUTE MYELOID LEUKEMIA (AML) are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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.

ACUTE MYELOID LEUKEMIA (AML) ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION (HCT) FLT3-ITD MUTATION GILTERITINIB MAINTENANCE THERAPY SORAFENIB

Contacts and locations

Locations

Ruijin Hospital, Shanghai Jiaotong University School of Medicine
RECRUITING

Shanghai, Shanghai Municipality, 200025, China
the First Affiliated Hosptital of Soochow University
RECRUITING

Suzhou, Jiangsu, 215006, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.