Testing two medicines together for hard-to-treat blood cancer

Plain-English translation of NCT05024552 on ClinicalTrials.gov ↗ · Source last updated December 2025 · Translation generated July 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This trial is testing combined with in patients whose acute myeloid leukemia (AML) has returned after treatment or no longer responds to previous medications. Both drugs target a specific mutation in the leukemia cells called FLT3. The study will first test different dose levels to find the safest combination, then expand to treat more patients at that dose.

When AML comes back or stops responding to standard treatment, patients have very limited options and outcomes are poor. This medication combination is designed to attack the leukemia in a new way, potentially offering hope to patients who have run out of other treatments.

Do you qualify?

You likely qualify if…

you have been diagnosed with acute myeloid leukemia that has a specific mutation called FLT3
your leukemia has either returned after previous treatment or has stopped responding to at least one prior treatment
your heart function is normal or near-normal (measured by ejection fraction of at least 50%)
your previous treatment with certain chemotherapy drugs was limited (no more than a specific cumulative dose)
you are able to take oral medication by mouth and follow the study plan
you have adequate organ function and are in generally stable health

You likely don't qualify if…

you have leukemia cells in your brain or central nervous system
your leukemia previously stopped responding to Gilteritinib specifically
you have severe stomach or intestinal problems that would prevent you from absorbing oral medications
you have uncontrolled infections, serious heart problems, or other serious illnesses that would make it unsafe to participate
you are currently taking other experimental cancer medications

What participation looks like

You will receive the two medications in phases: first an induction phase where you receive intravenous on specific days combined with daily oral pills. If your leukemia responds well, you may continue to a consolidation phase with the same medications. If you don't proceed to a stem cell transplant, you may enter a maintenance phase taking daily. The study involves regular clinic visits, blood tests, and monitoring to track how well the treatment is working and manage any side effects.

AI-generated summary from trial data · Jul 18, 2026 · Not medical advice

Trial locations(1 site)

United States

Moffitt Cancer Center, Tampa, Florida