RecruitingOBSERVATIONAL

Acute Myeloid Leukemia At Initial Diagnosis and/or Relapse in Children, Teenagers and Young Adults: Molecular Profiling, Multidrug Testing and MSC Interaction Studies

This study is looking into acute myeloid leukaemia (AML), a type of blood cancer, in children, teenagers, and young adults. Unfortunately, this cancer can be hard to treat, and it often comes back. The researchers want to understand why this happens by carefully looking at the cancer cells themselves. They will collect blood and bone marrow samples from patients to study the genetic makeup of these cells. This will help them identify what makes the cancer resistant to treatment or more likely to return. They also plan to test how different medicines affect these cancer cells in the lab. The goal is to find better ways to treat AML and improve the chances of recovery for young patients.

At a glance

Status

Recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

500

Start

31 May 2023

Estimated completion

31 May 2033

Acute Myeloid Leukemia Genetic Predisposition to Disease

What is this study about?

This research study is focused on a type of blood cancer called acute myeloid leukaemia (AML) that affects children, teenagers, and young adults. When young people get AML, it can be quite serious, and sometimes, even after treatment, the cancer can return. The doctors and scientists leading this study want to understand *why* this happens. They believe that by looking closely at the cancer cells, they can find clues that might explain why some treatments don't work as well or why the cancer comes back.

The main aim is to gather detailed information about the cancer cells from young patients. This involves collecting blood and bone marrow samples. By studying these samples, the researchers hope to map out the genetic changes within the cancer cells. This 'molecular profiling' is like creating a detailed picture of the cancer's inner workings. They'll be looking for specific changes that could predict whether the cancer is likely to be resistant to current treatments or if it has a high chance of returning after treatment.

Ultimately, the hope is that by understanding these hidden details of AML, doctors can develop more effective and tailored treatments in the future. They also plan to test different medicines directly on these cancer cells in the lab to see which ones work best. Another part of the study involves looking at how other cells in the bone marrow interact with the cancer cells, as this might also play a role in how the disease progresses.

Key takeaways

A study looking at acute myeloid leukaemia (AML) in children and young people.
Aims to understand why AML can be hard to treat or why it returns.
Involves collecting blood and bone marrow samples for detailed lab analysis.
Hopes to find clues in cancer cells to develop better future treatments.
Does not involve new treatments, but provides samples for research.
Open to patients up to 25 years old with AML or a genetic risk for it.

Who may be eligible?

This study is looking for children, teenagers, and young adults up to 25 years old. You might be able to join if you have been recently diagnosed with AML for the first time, or if your AML has come back, or if it isn't responding to treatment. They are also including people who have certain genetic conditions that make them more likely to develop AML.

In some cases, even if you don't have AML or a genetic risk for it, you might still be able to join if you are already having a bone marrow test as part of your regular medical care. This helps the researchers compare samples from people with and without AML. For anyone under 18, a parent or guardian will need to give permission, and if you're 18 or older, you will need to give your own permission.

However, you wouldn't be able to join if you have a different type of leukaemia called Chronic Myeloid Leukaemia (CML), if you are pregnant or breastfeeding, or if you simply don't wish to take part. There are also some legal or administrative reasons why you might not be able to join, such as not having health insurance in France if that is where the study is taking place.

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.

Are you 25 years old or younger?
Do you have Acute Myeloid Leukaemia (AML) that is new, has come back, or isn't responding to treatment?
Or do you have a genetic condition that makes you more likely to get AML?
Are you able to provide consent (or have a parent/guardian provide consent if under 18)?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve collecting samples of your blood and/or bone marrow. These samples will be taken either when you are first diagnosed with AML, or if your AML comes back or doesn't respond to treatment. The samples will be used for laboratory tests to understand the cancer cells better. There's no specific medication given as part of this study, nor additional hospital visits just for the research. The duration of your involvement would be based on when the samples are collected, and there isn't ongoing follow-up specifically for the research beyond that. This study is mainly about collecting and studying samples to gain knowledge, not about providing a new treatment.

Potential risks and benefits

Taking part in this study primarily involves providing blood and bone marrow samples, which are procedures you might be having as part of your standard medical care anyway. While these procedures carry minor risks like bruising or a small infection at the collection site, the study itself doesn't involve new medicines or treatments. The main benefit is knowing that your participation will help doctors and scientists learn more about AML in young people. This knowledge could lead to better ways to diagnose and treat the disease in the future, ultimately helping other children and young adults. You are always free to decide not to participate, or to withdraw from the study at any time, without it affecting your medical care.

Locations (28)

CHU Amiens Picardie site Sud
Verified postcode
Amiens, France· Recruiting
CHU Angers
Verified postcode
Angers, France· Recruiting
Hopital Minjoz
Verified postcode
Besançon, France· Recruiting
CHU Pellegrin
Verified postcode
Bordeaux, France· Recruiting
CHRU Morvan
Verified postcode
Brest, France· Recruiting
CHU Caen
Verified postcode
Caen, France· Recruiting
CHU Estaing
Verified postcode
Clermont-Ferrand, France· Recruiting
CHU Francois Mitterand
Verified postcode
Dijon, France· Recruiting
CHU Grenoble
Verified postcode
Grenoble, France· Recruiting
CHU de la Réunion
Verified postcode
La Réunion, France· Recruiting
Hopital Jeanne de Flandre - CHRU
Verified postcode
Lille, France· Recruiting
CHU Limoges
Verified postcode
Limoges, France· Recruiting

Common questions

What is AML?

AML stands for Acute Myeloid Leukaemia. It's a type of cancer that starts in the blood-forming cells in the bone marrow.

Why do they need blood and bone marrow samples?

Researchers need these samples to look at the cancer cells very closely, to understand their genetic makeup and why some treatments might not work or why the cancer comes back.

Will I get new medicine as part of this study?

No, this study is about collecting samples and studying them in the lab. It doesn't involve giving any new treatments or medications.

Who can join this study?

Children, teenagers, and young adults up to 25 years old with AML (newly diagnosed, relapsed, or resistant to treatment), or those with a genetic risk for AML can be considered.

What happens to my samples?

Your samples will be used by researchers to understand the cancer better, identify genetic changes, and test how different drugs affect the cancer cells in the lab.

How to find out more

Arnaud PETIT, Pr

arnaud.petit@aphp.fr +33 1 44 73 53 14 Official trial record

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