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Study on the Safety and Effectiveness of Fludarabine and Treosulfan for Stem Cell Transplant in Acute Myeloid Leukemia Patients Aged 40 to 65

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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 the treatment of Acute Myeloid Leukemia (AML), a type of cancer that affects the blood and bone marrow. The study will use a combination of two medications: Fludarabine and Treosulfan. These medications are part of a conditioning regimen, which is a treatment given to prepare the body for a stem cell transplant. The purpose of this study is to evaluate the safety and effectiveness of this treatment combination for patients with AML who are between the ages of 40 and 65 and are in complete remission, meaning their cancer is not currently active.

Participants in the study will receive the medications Fludarabine and Treosulfan through an infusion, which is a method of delivering medication directly into the bloodstream. The study will also involve the use of other medications, such as Ciclosporin, Mycophenolic Acid, Methotrexate Sodium, and Anti-T Lymphocyte Immunoglobulin, which are used to support the treatment and help prevent complications. These medications are given to help the body accept the new stem cells and to reduce the risk of the cancer returning.

The study will follow participants over a period of time to monitor their health and the effectiveness of the treatment. The main goal is to see how well patients do one year after receiving the stem cell transplant, specifically looking at whether they remain free of leukemia. This research aims to provide valuable information on how to improve treatment options for people with AML.

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
Initiation of treatment
The treatment begins with the administration of fludarabine and treosulfan. These medications are given through an infusion, which means they are delivered directly into the bloodstream via a vein.
The dosage of treosulfan is 14 grams. The specific dosage of fludarabine is not detailed here, but it is part of the conditioning regimen.
Step 2
Administration of additional medications
Following the initial treatment, other medications are administered to support the process. These include ciclosporin, mycophenolic acid, methotrexate sodium, and anti-t lymphocyte immunoglobulin from rabbits.
These medications are also given through infusion, except for ciclosporin, which is administered parenterally, meaning it is given by injection or infusion.
Step 3
Stem cell transplantation
After the conditioning regimen, the allogeneic stem cell transplantation (allo-SCT) takes place. This involves receiving healthy stem cells from a donor.
The goal of this step is to replace the patient's damaged or diseased bone marrow with healthy stem cells.
Step 4
Monitoring and follow-up
Post-transplantation, regular monitoring is conducted to assess the patient's response to the treatment and to ensure the safety and efficacy of the procedure.
The primary endpoint of the study is to evaluate the 1-year leukemia-free survival after the transplantation.

Who can join the trial?

8 criteria

Patients must be older than 40 years but younger than 65 years.
Must have a diagnosis of **Acute Myeloid Leukemia (AML)** and be in the first complete remission. This means the cancer is not currently detectable.
Eligible for a type of bone marrow transplant called **allo-SCT** from a donor who is a close genetic match. This is determined by a detailed test of certain genes called **HLA**.
Must have good liver function, meaning certain liver tests (bilirubin, ALT, and AST) should be within acceptable limits.
Must have good kidney function, with a creatinine clearance of at least 50 ml/min. This is a measure of how well the kidneys are working.
Must have an **ECOG Performance Status** of less than 2. This is a scale that measures how well a person can perform daily activities.
Must be willing and able to follow all the study requirements and attend all visits.
Must provide written and signed informed consent, which means they understand the study and agree to participate.

Who cannot join the trial?

4 criteria

Patients who are not in complete morphological remission. This means the cancer is not fully under control or has not disappeared as seen under a microscope.
Patients who are younger than 40 years old or older than 65 years old.
Patients who are not diagnosed with Acute Myeloid Leukemia (AML).
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
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Azienda Ospedaliero Universitaria Di Sassari
Sassari, Italy
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Universita' Degli Studi Di Verona
Verona, Italy

Trial locations

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Investigated drugs

Fludarabine
is a medication used to weaken the immune system before a stem cell transplant. It helps to prepare the body to accept new stem cells by reducing the activity of the immune system, which can attack the transplanted cells.
Treosulfan
is a chemotherapy drug used in combination with other medications to prepare patients for a stem cell transplant. It works by killing cancer cells and suppressing the immune system to help the body accept the new stem cells.
FT14 Conditioning Regimen
refers to the combination of Fludarabine and Treosulfan used together to prepare patients with Acute Myeloid Leukemia for an allogeneic stem cell transplant. This regimen aims to ensure the safety and effectiveness of the transplant process.

What is already known about the treatment

Fludarabine
Fludarabine is administered intravenously and is used in combination with other medications for conditioning regimens before stem cell transplantation. It is currently being studied in clinical trials for its safety and effectiveness in treating Acute Myeloid Leukemia (AML). The main therapeutic indication is for patients with AML who are in complete remission. Fludarabine works by interfering with the DNA synthesis of cancer cells, thereby inhibiting their growth and proliferation. It is classified as an antimetabolite and is commonly used in chemotherapy protocols.
Treosulfan
Treosulfan is given intravenously and is part of a conditioning regimen for patients undergoing stem cell transplantation. It is being evaluated in clinical trials for its role in treating Acute Myeloid Leukemia (AML). The primary therapeutic use is for AML patients in remission who are preparing for transplantation. Treosulfan acts by alkylating DNA, leading to the disruption of cancer cell replication. It is classified as an alkylating agent and is used to prepare the body for receiving new stem cells.

Investigated diseases

Acute Myeloid Leukemia (AML) – Acute Myeloid Leukemia is a type of cancer that starts in the blood-forming cells of the bone marrow. It progresses rapidly, leading to the accumulation of immature white blood cells called myeloblasts. These cells crowd out normal blood cells, causing symptoms like fatigue, frequent infections, and easy bruising or bleeding. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. AML is characterized by its quick onset and the need for prompt medical attention. The disease is more common in adults and can vary in its specific genetic mutations and subtypes.