RecruitingOBSERVATIONAL

Analysis of Biomarkers in Patients With Acute Myeloid Leukemia After Allogeneic Stem Cell Transplantation Treated With Menin Inhibition.

This study is investigating acute myeloid leukaemia in people whose illness has unfortunately returned after they've had a stem cell transplant. Researchers are looking closely at certain markers, like special proteins or genetic changes, in their white blood cells. This is to understand why the leukaemia came back and how it behaves. The insights gained from this study could help doctors develop more effective treatments in the future, particularly those that use 'menin inhibition' – a new type of treatment. They are focusing on specific types of leukaemia with certain genetic changes, hoping to improve care for these patients.

At a glance

Status

Recruiting

Sponsor

University of Freiburg

Enrolment target

Start

30 May 2026

Estimated completion

30 May 2027

Acute Myeloid Leukemia

What is this study about?

This research study is focused on a type of blood cancer called acute myeloid leukaemia (AML). Specifically, it's looking at people who have already undergone a special treatment called an allogeneic stem cell transplant, but whose AML has sadly returned. A stem cell transplant involves replacing unhealthy blood cells with healthy ones from a donor, and it's a major treatment for AML. However, sometimes the cancer can come back, which is called a relapse.

The main goal of this study is to investigate certain 'biomarkers' in the white blood cells of these patients. You can think of biomarkers as clues or signals within the body that can tell us about a disease. In this case, the researchers are looking at clues that might explain why the AML came back and how it's behaving. They are particularly interested in patients whose AML has specific genetic changes, known as NPM1 mutations or KMT2A rearrangements.

By understanding these biomarkers better, the scientists hope to learn more about the AML that returns after a transplant. This knowledge could be really important for developing new and more effective treatments. They are especially interested in how a new type of treatment, called 'menin inhibition' (which blocks a specific protein involved in some AMLs), might work in these patients. Ultimately, this study aims to improve understanding and discover new ways to help people living with AML after a relapse.

Key takeaways

This study is for people with acute myeloid leukaemia (AML).
It's for those whose AML has returned after a stem cell transplant.
Researchers are looking for 'clues' (biomarkers) in blood cells.
The focus is on AML with specific genetic changes.
The aim is to understand the disease better and help develop future treatments.

Who may be eligible?

To join this study, people must meet specific requirements. First, you must have been diagnosed with acute myeloid leukaemia that has certain genetic changes. These are known as NPM1 mutations or KMT2A rearrangements. These are particular features of your leukaemia that the doctors will know about.

Secondly, your leukaemia must have unfortunately returned after you have already had an allogeneic stem cell transplant. This study is specifically for people who have experienced this relapse after their transplant. You also need to be 18 years old or older to take part.

Finally, to be included, you must be willing and able to give your informed consent. This means understanding what the study involves and agreeing in writing to participate. If you are unable to provide this consent, you would not be able to join the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have been diagnosed with acute myeloid leukaemia (AML).
My AML has certain genetic changes (NPM1 mutations or KMT2A rearrangements).
My AML has come back after I had a stem cell transplant.
I am 18 years old or older.
I am willing to discuss and sign an informed consent form.

Answer every question to see your result.

What does participation involve?

The information provided is a brief summary, so it doesn't give full details on what taking part would involve. However, generally in studies like this, participants would likely undergo several assessments. This could include providing blood samples regularly so researchers can analyse the biomarkers mentioned. You might also have physical examinations and answer questions about how you are feeling and any symptoms you experience. The duration of your participation and the frequency of visits would depend on the study design, but it usually involves a period of monitoring and follow-up. This study does not mention specific medication being given, but it focuses on analysing white blood cells to understand the disease better.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that it might help researchers learn more about your specific type of leukaemia, which could lead to better treatments in the future for you or others. However, there's no guarantee that participating will directly benefit your health immediately. Possible risks often include the discomfort of blood draws or additional clinic visits. You will be fully informed about all known risks before deciding to join. It's very important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University of Freiburg Mdical Center
Verified postcode
Freiburg im Breisgau, Germany· Recruiting

Common questions

What is 'acute myeloid leukaemia'?

It's a type of cancer that affects the blood and bone marrow, where new blood cells are made.

What is an 'allogeneic stem cell transplant'?

This is a treatment where unhealthy blood cells are replaced with healthy ones from a donor.

What are 'biomarkers'?

These are clues or signals found in the body, like special proteins or genes, that can tell doctors about a disease.

What does it mean if my leukaemia has 'relapsed'?

It means the leukaemia has unfortunately returned after a period of treatment, such as a stem cell transplant.

Will I get a new treatment in this study?

This study focuses on understanding the disease through analysing blood samples, not on giving new treatments. The goal is to find information that could lead to new treatments later.

How to find out more

Robert Zeiser, MD

robert.zeiser@uniklinik-freiburg.de +4976127034020 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.