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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 study about?

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Azienda Ospedaliero Universitaria Di Sassari Sassari Italy

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Azienda Ulss 3 Serenissima Venice Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi Ancona Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli Reggio Calabria Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Universita’ Degli Studi Di Verona Verona Italy
San Raffaele Scientific Institute Milan Italy
Azienda Sanitaria Territoriale Di Ascoli Piceno Ascoli Piceno Italy
Universita Degli Studi Di Brescia Brescia Italy
Ospedale S. Eugenio Rome Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not yet recruiting
30.09.2022

Trial locations

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.

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.

Trial ID:
2024-520326-11-00
Trial Phase:
Therapeutic exploratory (Phase II)

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