New triple therapy targets FLT3-Mutated leukemia in frail patients

NCT ID NCT05520567

Ongoing Disease control Sponsor: Astellas Pharma Global Development, Inc. Source: ClinicalTrials.gov ↗

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.

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

Get updates

Get notified about this study

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 neoplasm

As listed by the trial registrant

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

ACUTE MYELOID LEUKEMIA (AML) FLT3-MUTATED ACUTE MYELOID LEUKEMIA

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

More trials for these conditions

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