Not yet recruitingRare disease

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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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
Step 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
Step 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
Step 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 trial?

13 criteria

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 trial?

13 criteria

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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Responsive
Palermo, Italy
Azienda Ospedaliera Universitaria Senese
Responsive
Siena, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy

Trial locations

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Investigated drugs

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.

Gilteritinib

What is already known about the treatment

Gilteritinib
An oral targeted therapy medication used in the treatment of acute myeloid leukemia (AML) with FLT3 mutations. This drug works by blocking the FLT3 protein pathway that promotes cancer cell growth, effectively stopping the proliferation of leukemia cells. Gilteritinib belongs to the class of tyrosine kinase inhibitors and is typically administered in combination with standard chemotherapy drugs like fludarabine, cytarabine, and idarubicin as part of induction therapy for newly diagnosed AML patients.
Fludarabine
An intravenous chemotherapy medication used in combination therapy for acute myeloid leukemia. It works by interfering with DNA synthesis in cancer cells, preventing them from multiplying and causing cell death. This antimetabolite drug belongs to the class of purine analogs and is commonly used alongside other chemotherapy agents as part of intensive induction therapy protocols.
Cytarabine
An injectable chemotherapy drug that is a cornerstone in the treatment of acute myeloid leukemia. It functions by blocking DNA synthesis in rapidly dividing cells, particularly targeting cancer cells during their growth phase. This antimetabolite medication is typically administered intravenously as part of combination chemotherapy regimens and is considered a standard component of AML induction therapy.
Idarubicin
An intravenous anthracycline antibiotic used in combination chemotherapy for acute myeloid leukemia. It works by interfering with DNA and RNA synthesis in cancer cells, preventing their reproduction and causing cell death. This medication belongs to the class of anthracyclines and is commonly included in intensive induction therapy protocols for newly diagnosed AML patients.

Investigated diseases

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.