Prospective Phase II study on Safety and Efficacy of Fludarabine plus Treosulfan (14g) (FT14) conditioning regimen for allogeneic Stem Cell Transplantation (allo-SCT) in Acute Myeloid Leukemia (AML) patients (≥40 <65years)
This research study, called a Phase II trial, is investigating a new treatment approach for people with a type of blood cancer called Acute Myeloid Leukaemia (AML). Specifically, it's looking at how well and how safely two medicines, Fludarabine and Treosulfan, work together as a 'conditioning regimen' before a stem cell transplant. A conditioning regimen helps prepare the body for the transplant. The study is focusing on adults with AML aged between 40 and 65 years old. The main goal is to find out if this treatment helps people stay free of leukaemia for at least one year after their transplant.
At a glance
What is this study about?
This study is about finding a better way to treat Acute Myeloid Leukaemia (AML), which is a type of cancer that starts in the blood cells. One common treatment for AML is a stem cell transplant. Before you can have a stem cell transplant, your doctors need to give you strong medicines to prepare your body. This preparation is called a 'conditioning regimen'.
Currently, doctors use different conditioning regimens. This study is testing a specific new combination of two medicines: Fludarabine and Treosulfan. The aim is to see if this combination is a safe and effective way to prepare AML patients for a stem cell transplant, especially for those aged between 40 and 65. The hopeful outcome is that this new approach will help more patients stay healthy and free from their leukaemia after their transplant.
This is a 'Phase II' study, which means it's one of the earlier steps in testing a new treatment. We already have some information about these medicines, but this study is designed to gather more specific details about their safety and how well they work together in this particular group of patients. The main thing researchers want to know is if patients are still free of leukaemia one year after their transplant using this new conditioning regimen.
Key takeaways
- This study explores a new way to prepare for stem cell transplants in AML.
- It's testing a combination of two chemotherapy drugs: Fludarabine and Treosulfan.
- The main goal is to see if this treatment helps patients stay leukaemia-free for at least one year.
- This is a Phase II study, gathering more information on safety and effectiveness.
- It's aimed at adults with AML who are candidates for a stem cell transplant.
Who may be eligible?
This study is open to adults aged 18 and over who have Acute Myeloid Leukaemia (AML). While the title mentions a focus on those aged 40 to 65, the full criteria would be checked by the study team. You would need to have AML and be considered for a stem cell transplant.
There might be other health conditions or treatments that could affect whether you can join the study. For example, your overall health, how your kidneys and liver are working, and any other serious medical problems might be important. The study team will review your complete medical history to make sure the study is a good fit for you.
Both men and women can take part in this study. The most important thing is that your doctors believe this specific conditioning treatment with Fludarabine and Treosulfan might be a suitable option for your AML.
- Am I an adult (18 years or older)?
- Do I have Acute Myeloid Leukaemia (AML)?
- Am I being considered for a stem cell transplant?
- Am I generally well enough to undergo intensive treatment?
- Does my doctor think this specific treatment combination could be right for me?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would first have a number of tests and checks to make sure you're suitable. Once enrolled, you would receive the study medications, Fludarabine and Treosulfan, as part of your conditioning treatment before your stem cell transplant. These medicines are given as a drip into your vein.
You would also receive other standard medications given during a transplant, such as Ciclosporin, Methotrexate, and special antibodies (Antithymocyte Immunoglobulin/Grafalon) to help prevent your body from rejecting the new stem cells and to control side effects. You would likely stay in the hospital for some time around the transplant.
After your transplant, you would have regular follow-up appointments, including blood tests and check-ups with your doctors, to monitor your health, how effectively the new stem cells are working, and to keep an eye out for any side effects. These follow-up visits would continue for a certain period, and the overall duration of your involvement in the study would depend on your recovery and the specific follow-up schedule.
Potential risks and benefits
Locations (1)
- —Italy
Common questions
What is 'Acute Myeloid Leukaemia (AML)'?
AML is a type of cancer that affects the blood and bone marrow, where blood cells are made. It causes your body to produce too many faulty white blood cells.
What is a 'stem cell transplant'?
A stem cell transplant replaces unhealthy blood-forming cells in your bone marrow with healthy ones, usually from a donor or sometimes from yourself.
What is a 'conditioning regimen'?
A conditioning regimen is the treatment, often with chemotherapy, given before a stem cell transplant. It helps prepare your body for the new stem cells.
What are 'Fludarabine' and 'Treosulfan'?
These are chemotherapy medicines that are being tested together in this study. They work by targeting and destroying cancer cells.
What does 'leukaemia-free survival' mean?
Leukaemia-free survival means the length of time a person lives without their leukaemia coming back after treatment. The study is looking at this for one year.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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