Study of gilteritinib with fludarabine, cytarabine and idarubicin combination therapy in newly diagnosed FLT3-positive acute myeloid leukemia patients

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What is this study about?

This clinical study focuses on patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-positive. The study will test a combination treatment approach using gilteritinib (also known as Xospata) together with three chemotherapy medications: fludarabine, cytarabine, and idarubicin. Acute myeloid leukemia is a type of blood cancer that affects the bone marrow and blood cells.

The purpose of this research is to determine how well patients respond to the combination of gilteritinib with chemotherapy and how well they tolerate this treatment. During the study, participants will receive gilteritinib tablets taken by mouth along with the chemotherapy medications. The maximum daily dose of gilteritinib will be 120 mg, and the treatment may continue for up to 15 months.

The treatment will be given in courses, and doctors will monitor how the disease responds to the therapy. They will check if the cancer goes into remission (when cancer cells are no longer detected or are significantly reduced) and will track the overall health of participants throughout the study period. The study will also look at how long any positive treatment effects last and how the treatment affects patients’ quality of life.

1 Initial medical assessment

Your medical condition must be confirmed as newly diagnosed non-M3 FLT3-positive acute myeloid leukemia

Medical tests will be performed to check your organ function, including heart (LVEF test and ECG), kidney, and liver function tests

A pregnancy test will be required if you are a woman who can become pregnant

2 Treatment course 1

You will receive a combination treatment consisting of gilteritinib (Xospata 40 mg tablets) taken by mouth and chemotherapy

The chemotherapy includes three medications: fludarabine, cytarabine, and idarubicin (FLAI)

Your response to the treatment will be monitored through medical tests

3 Treatment course 2 (if needed)

A second course of treatment may be given if necessary

The same combination of medications will be used as in course 1

Regular testing will continue to monitor your response to treatment

4 Monitoring period

Your condition will be regularly monitored through blood tests and other medical examinations

The effectiveness of the treatment will be assessed by checking for signs of disease in your blood and bone marrow

Your quality of life will be evaluated throughout the study period

5 Follow-up period

You will need to continue using two forms of birth control during treatment and for 6 months after treatment ends

Regular follow-up visits will be scheduled to monitor your long-term health status

The study will track your progress to assess how long the treatment effects last

Who Can Join the Study?

Age between 18 and 65 years old
Have a performance score of 0 to 2 on the ECOG scale (a measure of a person’s ability to perform daily activities)
Have adequate heart function, including:
- Normal heart pumping ability as measured by special heart tests
- Normal heart rhythm on ECG (heart electrical activity test)
Have adequate kidney function, shown by normal or near-normal blood creatinine levels
Have adequate liver function, shown by:
- Near-normal bilirubin levels (a substance processed by the liver)
- Near-normal liver enzyme levels (AST and ALT)
Test positive for FLT3 mutation (a specific genetic change) in bone marrow or blood
Have newly diagnosed acute myeloid leukemia (non-APL type)
For women who can become pregnant:
- Must have a negative pregnancy test within 1 week before starting treatment
All participants must use two acceptable forms of birth control during the study and for 6 months after treatment ends
Must sign an informed consent form before starting any study procedures
Must be able to follow the study schedule and attend all required visits

Who Cannot Join the Study?

Patients with acute promyelocytic leukemia (M3 subtype of acute myeloid leukemia)
Patients who do not have a FLT3 mutation (a specific genetic change in leukemia cells)
Patients under 18 years of age
Patients who are pregnant or breastfeeding
Patients with severe kidney problems (severe renal impairment)
Patients with severe liver problems (severe hepatic dysfunction)
Patients with uncontrolled active infections
Patients who have received any other investigational drugs within 14 days before starting this treatment
Patients with known allergies to the study medications
Patients with serious heart conditions that are not well controlled
Patients who cannot understand or follow study instructions
Patients who have had other types of cancer in the past 2 years (except for adequately treated skin cancer or cervical cancer)
Patients with serious psychiatric conditions that could interfere with the study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Ospedale dell’Angelo di Mestre	Mestre – Venezia	Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Hospital Santa Maria Della Misericordia	Perugia	Italy
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Azienda Sanitaria Locale Di Pescara	Pescara	Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli	Reggio Calabria	Italy
Istituto Oncologico Veneto	Padua	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Politecnica Delle Marche	Ancona	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Axiofqp Oygynghipmc Opsdpign Rhglsns Vpvhy Sqrnf Ciponrbt	Palermo	Italy
Aoumdqc Ohlrxwzxynt Ubuqspspcydql Sbdqlt	Siena	Italy
Apkxcjb Owryopqzjdz Uzvvjqmcoxvul Cftixlwcphaw Dwhok Smnqfz E Dhyjq Sludbvf Do Thyktd	Turin	Italy
Artlufb Uht Iyrkf Db Rkojqv Exqksx	Reggio Emilia	Italy
Afwytzg Uclkq Sxqnqsljn Lzihxt Dx Bcwtbtw	Bologna	Italy
Anuilec Ojmytarmzwe Pxut Gsakfpgd Xpnzw	Bergamo	Italy
Ukzaxegswe Dzgmm Sfsao Dj Reyz Lb Sjaiqnhj	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	30.09.2025

Trial locations

Investigated drugs:

Gilteritinib

Gilteritinib is a targeted therapy medication used to treat acute myeloid leukemia (AML) that has a specific genetic mutation called FLT3. It works by blocking the abnormal FLT3 protein that helps cancer cells grow.

Fludarabine is a chemotherapy medication that works by interfering with cancer cell DNA, which helps stop cancer cells from growing and dividing.

Cytarabine is a chemotherapy medication that works by preventing cancer cells from making and repairing DNA, which stops them from multiplying.

Idarubicin is a chemotherapy medication that belongs to a class called anthracyclines. It works by damaging the DNA of cancer cells, which prevents them from growing and spreading.

These medications are used together (known as FLAI combination therapy) to treat newly diagnosed acute myeloid leukemia patients who have the FLT3 genetic mutation.

Investigated diseases:

Acute myeloid leukaemia

Acute Myeloid Leukemia (non-M3 FLT3-positive) – A type of blood and bone marrow cancer that affects the myeloid cells, which normally develop into various types of blood cells. In this specific form, there is a mutation in the FLT3 gene, which causes abnormal growth and division of white blood cells. The disease develops rapidly, with immature blood cells (called blasts) accumulating in the bone marrow and interfering with the production of normal blood cells. This condition specifically excludes the M3 subtype (acute promyelocytic leukemia) and is characterized by the presence of the FLT3 gene mutation. The abnormal cells can quickly spread into the bloodstream and potentially affect other parts of the body.

Trial ID:

2024-518617-25-00

NCT ID:

NCT06667973

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of gilteritinib with fludarabine, cytarabine and idarubicin combination therapy in newly diagnosed FLT3-positive acute myeloid leukemia patients

What is this study about?

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