Acute Myeloid Leukemia: Gilteritinib vs. Midostaurin

We are studying whether gilteritinib works better than midostaurin for patients with AML or MDS with a FLT3 mutation. This trial looks at treatment effectiveness and safety during chemotherapy and maintenance therapy.

1-2 yearsEfficacy phase (II)No PlaceboStandard MedicinesOralHematologyOncology

What diseases are being studied?

Health conditions and diseases that the clinical trial is designed to study and treat.

Who can participate in the clinical trial?

These questions help us understand your situation so we can let the trial team know whether you might be a potential match. This is not a medical evaluation and is not part of the official screening, the study doctor will make the final decision..

What medicines are being studied?

Medicines that are officially approved for use in the European Union and considered safe by EMA. These medicines are already on the market and may be tested for new conditions or populations.

Rydapt
Rydapt is a cancer medicine used to treat certain types of blood cancers, including some forms of acute myeloid leukemia and advanced systemic mastocytosis.
Xospata
Xospata is a medicine used to treat adults with relapsed or refractory acute myeloid leukemia, a blood cancer linked to a specific gene change.

What active substances are being studied?

Active substances that are officially approved for use in the European Union and considered safe by EMA. These substances are already on the market and may be tested for new conditions or populations.

Gilteritinib
Gilteritinib is a substance that targets leukemia cells with a specific genetic mutation to help treat relapsed or refractory acute myeloid leukemia.
Midostaurin
Midostaurin is a targeted cancer substance that blocks proteins driving growth of certain blood cancers, such as FLT3‑mutated acute myeloid leukemia.

Where is the clinical trial being conducted?

Locations and medical facilities where this clinical trial is currently recruiting or conducting research. Select the locations where you would like to participate.

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Ordensklinikum Linz GmbH
Hematology
Linz, Austria
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
Hematology
Vienna, Austria
Het Ziekenhuisnetwerk Antwerpen
Hematology
Borgerhout, Belgium
Sponsor: Haemato Oncology Foundation For Adults Netherlands (HOVON)
Last updated: Nov 26, 2025

Disclaimer: Parts of this content have been automatically extracted from the EU Clinical Trials registry. While we strive for accuracy, please always contact the trial site or sponsor directly for correct and official information before making any decisions about participation. View on EU Clinical Trials.