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Study of Gilteritinib and Azacitidine for Newly Diagnosed Acute Myeloid Leukemia with FLT3 Mutation in Patients Not Eligible for Intensive Chemotherapy

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 trial is focused on studying a type of blood cancer called Acute Myeloid Leukemia (AML) that has a specific genetic change known as the FLT3 mutation. The study is for patients who have been newly diagnosed with this condition and are not able to undergo intensive chemotherapy. The trial is testing the effectiveness of a medication called Gilteritinib, also known by its code name ASP2215, both on its own and in combination with another medication called Azacitidine. Azacitidine is also being tested alone to see how it compares to the other treatments.

The purpose of the study is to find out which treatment option helps patients live longer. Participants in the study will be randomly assigned to receive either Gilteritinib, a combination of Gilteritinib and Azacitidine, or Azacitidine alone. The study will monitor the participants over a period to observe their overall health and how well they respond to the treatment. The study will also look at other factors such as how long patients remain free of leukemia and their quality of life during the treatment.

Throughout the study, participants will have regular check-ups, including blood tests and other assessments, to ensure their safety and to gather information on how the treatments are working. The study aims to provide valuable insights into the best treatment options for patients with this specific type of leukemia who cannot undergo more aggressive chemotherapy treatments.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, the patient is confirmed to have a diagnosis of acute myeloid leukemia with a specific genetic mutation known as FLT3. This diagnosis is verified by a pathology review at the treating institution.

    The patient is assessed to ensure they are not eligible for intensive induction chemotherapy. This assessment is based on age or certain health conditions that make intensive treatment unsuitable.

  2. Step 2

    Randomization

    The patient is randomly assigned to one of the treatment groups. This process ensures that each patient has an equal chance of receiving any of the treatments being studied.

  3. Step 3

    Treatment administration

    The patient receives one of the following treatments: azacitidine alone, gilteritinib alone, or a combination of both.

    Azacitidine is administered as a suspension for injection. The specific dosage and frequency are determined by the study protocol.

    Gilteritinib is provided in the form of film-coated tablets, taken orally. The dosage and frequency are also specified in the study protocol.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, the patient's health is closely monitored. This includes regular physical examinations, blood tests, and other necessary assessments to track the patient's response to treatment.

    The primary goal is to evaluate overall survival, while secondary goals include assessing event-free survival, best response, and other health outcomes.

  5. Step 5

    Completion of the study

    The study is expected to conclude by the end of 2024. At this point, the collected data will be analyzed to determine the effectiveness and safety of the treatments.

Who can join the trial?

12 criteria

  • The patient must have a diagnosis of **Acute Myeloid Leukemia (AML)** that has not been treated before. This is a type of blood cancer.
  • The patient must have a **FLT3 mutation**. This is a specific change in the genes that can affect how the leukemia behaves.
  • The patient must not be eligible for **intensive induction chemotherapy**. This means they cannot undergo a strong initial treatment for leukemia. This can be due to:
  • Being 65 years or older and not suitable for intensive treatment as decided by the doctor.
  • Being between 18 to 64 years old and having certain health issues, such as:
  • **Congestive heart failure** with certain limitations in heart function.
  • High levels of **creatinine** in the blood, which indicates kidney problems, or having had a kidney transplant.
  • An **ECOG performance status** of 2 or higher, which means the patient has some difficulty in daily activities.
  • Having another cancer that does not need treatment at the same time.
  • Having received a high dose of a type of cancer drug called **anthracycline**.
  • Having lung disease that affects breathing and requires oxygen support.
  • Any other health issue that the doctor believes makes intensive chemotherapy unsuitable, which must be approved by a medical expert before joining the study.
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Investigated drugs

  • Gilteritinib

    This medication is used in the treatment of acute myeloid leukemia (AML) with a specific genetic mutation known as FLT3. It works by blocking certain proteins that help cancer cells grow, which may slow down or stop the progression of the disease.

  • Azacitidine

    This is a chemotherapy drug used to treat certain types of blood cancers, including acute myeloid leukemia (AML). It works by interfering with the growth of cancer cells, which can help to control the disease and improve survival.

What is already known about the treatment

  • Gilteritinib

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating acute myeloid leukemia (AML) with a specific genetic mutation known as FLT3. It is not yet fully established in medical practice but shows promise in medical literature. Gilteritinib works by inhibiting the activity of the FLT3 protein, which is involved in the growth and survival of cancer cells. It is classified as a tyrosine kinase inhibitor, a type of drug that blocks signals needed for tumors to grow.

  • Azacitidine

    This medication is given by injection and is used in the treatment of certain types of blood cancers, including acute myeloid leukemia (AML). It is well-established in medical practice and literature. Azacitidine works by incorporating into the DNA of cancer cells, leading to changes that can stop the growth of these cells. It is classified as a nucleoside metabolic inhibitor, which helps to restore normal function to the bone marrow and reduce the number of abnormal blood cells.

Investigated diseases

Acute Myeloid Leukemia with FLT3 Mutation – This is a type of cancer that affects the blood and bone marrow, characterized by the rapid growth of abnormal white blood cells. The FLT3 mutation is a genetic change that can occur in these leukemia cells, leading to more aggressive disease behavior. Patients with this mutation often experience symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The disease progresses as these abnormal cells accumulate, interfering with the production of normal blood cells. Over time, this can lead to anemia, increased risk of infections, and other complications. The condition is particularly challenging in patients who are not eligible for intensive chemotherapy treatments.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512474-98-00Protocol code2215-CL-0201Estimated enrolment96 patientsSponsorAstellas Pharma Global Development Inc.

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