Not recruiting

Study on Azacitidine and Gilteritinib for Adults with Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia

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), specifically in patients whose cancer has returned or did not respond to initial treatment. The study is looking at patients who have a specific genetic change known as the FLT3 mutation. The trial will test the effectiveness and safety of adding a medication called oral azacitidine to another treatment known as gilteritinib. These medications are taken as tablets by mouth.

The purpose of the study is to see how well the combination of these two medications works in achieving a response in the cancer, such as reducing the number of cancer cells in the body. The study will last for about six months, during which participants will receive the treatment and be monitored for any changes in their condition. The study will also look at the safety of the treatment by observing any side effects that may occur.

Participants in the study will be adults aged 18 and older who have been diagnosed with acute myeloid leukemia and have the FLT3 mutation. The study aims to provide more information on how these medications can be used together to help patients with this type of cancer. The results will help doctors understand if this combination of treatments can be a beneficial option for patients with relapsed or refractory acute myeloid leukemia.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of treatment
Upon joining the study, you will begin the treatment phase. This involves taking specific medications as prescribed by the study protocol.
You will be administered azacitidine in tablet form. The dosage will be either 300 mg or 200 mg, taken orally. The exact dosage and frequency will be determined by the study team based on your individual needs.
Additionally, you will take gilteritinib, which is provided as a 40 mg film-coated tablet. This medication is also taken orally. The study team will provide specific instructions regarding the dosage and frequency.
Step 2
Treatment duration
The treatment phase is expected to last for a period of three months. During this time, the study team will monitor your response to the medications.
The main goal is to assess the effectiveness of the treatment by observing the rate of composite complete remission, which includes complete remission, complete remission with incomplete blood cell recovery, and complete remission with incomplete platelet recovery.
Step 3
Monitoring and assessments
Throughout the study, regular assessments will be conducted to monitor your health and the effects of the treatment.
These assessments may include blood tests, physical examinations, and other necessary evaluations to ensure your safety and to gather data on the treatment's effectiveness.
Step 4
End of treatment phase
At the end of the three-month treatment phase, the study team will conduct a final assessment to evaluate your response to the treatment.
Based on the results, further steps will be discussed, which may include additional treatment options or follow-up care as necessary.

Who can join the trial?

15 criteria

Must be at least 18 years old.
Have a confirmed diagnosis of acute myeloid leukemia (AML), a type of blood cancer.
Have a specific genetic change called FLT3 mutation.
The disease must have returned or not responded to the first treatment.
Have never received a drug called oral azacitidine.
Must be able to take medication by mouth.
Have proper functioning of major organs, including kidneys, liver, and heart.
Have an ECOG performance status of less than 3, which means being able to carry out daily activities with some limitations.
Must not have any conditions that would make it difficult to follow the study requirements.
Women must not be pregnant and must agree to use birth control during the study and for a period after.
Women must agree not to breastfeed during the study and for a period after.
Women must agree not to donate eggs during the study and for a period after.
Men with partners who can become pregnant must agree to use birth control during the study and for a period after.
Men must agree not to donate sperm during the study and for a period after.
Must provide written consent to participate in the study.

Who cannot join the trial?

4 criteria

Patients who do not have a **FLT3 mutation** in their acute myeloid leukemia. FLT3 mutation is a specific change in the DNA of leukemia cells that can affect how the disease behaves and responds to treatment.
Patients who are under 18 years old.
Patients who have not experienced a **relapse** or whose leukemia is not **refractory**. A relapse means the cancer has returned after treatment, and refractory means the cancer does not respond to treatment.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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

Assistance Publique Hopitaux De Paris
Verified
Paris, France
CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France
CHU Grenoble Alpes
Verified
La Tronche, France

Trial locations

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Investigated drugs

Oral-Azacitidine
is a medication used in this clinical trial to help treat a type of blood cancer called acute myeloid leukemia (AML). It works by interfering with the growth of cancer cells, which can help to slow down or stop the progression of the disease. In this study, oral-azacitidine is being tested to see how well it works when combined with another medication, gilteritinib, for patients whose cancer has returned or has not responded to previous treatments.
Gilteritinib
is another medication used in this trial, specifically for patients with a type of acute myeloid leukemia that has a mutation in the FLT3 gene. This medication targets and blocks the activity of the FLT3 protein, which is often involved in the growth and survival of cancer cells. By inhibiting this protein, gilteritinib can help to reduce the number of cancer cells in the body. The trial is investigating how effective gilteritinib is when used together with oral-azacitidine for treating this specific type of leukemia.

What is already known about the treatment

Oral-Azacitidine
Oral-Azacitidine is administered in pill form and is taken by mouth. It is currently being studied in clinical trials for its effectiveness and safety when combined with another medication, gilteritinib, for treating adults with a specific type of blood cancer called FLT3-mutated acute myeloid leukemia that has returned or is resistant to treatment. The main purpose of this medication is to help achieve remission, which means reducing the cancer to undetectable levels. At the molecular level, Oral-Azacitidine works by interfering with the DNA of cancer cells, preventing them from growing and multiplying. It is classified as a type of chemotherapy drug.
Gilteritinib
Gilteritinib is taken orally in tablet form and is used in combination with Oral-Azacitidine in clinical trials to treat adults with relapsed or refractory FLT3-mutated acute myeloid leukemia. This medication is already approved for use in certain cases of acute myeloid leukemia and is being further studied to enhance its effectiveness. Gilteritinib targets and blocks a specific protein, FLT3, which is often mutated in this type of leukemia, thereby inhibiting the growth of cancer cells. It belongs to a class of drugs known as tyrosine kinase inhibitors.

Investigated diseases

Acute Myeloid Leukemia with FLT3 Mutation – Acute Myeloid Leukemia (AML) is a type of cancer that affects the blood and bone marrow, characterized by the rapid growth of abnormal white blood cells. In cases with FLT3 mutation, there is a specific genetic alteration that leads to the uncontrolled proliferation of these cells. The disease progresses as these abnormal cells accumulate, interfering with the production of normal blood cells. This can lead to symptoms such as fatigue, frequent infections, and easy bruising or bleeding. Over time, the bone marrow becomes increasingly filled with these leukemia cells, further reducing the body's ability to produce healthy blood cells. The progression of the disease can vary, but it typically involves a worsening of symptoms as the number of leukemia cells increases.