RecruitingNAINTERVENTIONAL

Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia

This study is investigating a new treatment called 'micro-transplantation' for older patients (aged 60-75) with acute myeloid leukaemia, often called AML. AML is a serious blood cancer. Standard stem cell transplants are often not suitable for older patients due to potential side effects and health conditions. This new micro-transplantation method involves giving a small number of donor cells after initial chemotherapy. The aim is to help the body fight the cancer without the risks of a full transplant, like serious graft-versus-host disease where the new cells attack the patient's body. The researchers want to find out if this treatment is safe and truly helpful for people who have limited options.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrolment target

Start

08 Jan 2019

Estimated completion

31 Dec 2027

Acute Myeloid Leukemia

What is this study about?

Acute myeloid leukaemia (AML) is a type of blood cancer that usually affects older people, often around 65 years old. It can be quite aggressive, and sadly, treatments haven't always been as successful as we'd like for older patients. Doctors have to think about a patient's overall health and other medical conditions when deciding on the best treatment.

One of the most effective treatments for AML is something called an allogeneic stem cell transplant, where you receive healthy blood-forming cells from a donor. However, this treatment can be very challenging and carries significant risks and side effects, making it unsuitable for many older patients. This study is for those older patients who can't have that standard transplant.

This research is exploring a new idea called 'micro-transplantation'. It's not a full stem cell transplant. Instead, after a patient has had initial chemotherapy to treat the leukaemia, they receive a small number of special cells from a donor who isn't a perfect match. The idea is that these donor cells can help fight the leukaemia without causing the severe problems and side effects that sometimes happen with a full transplant. This study wants to see how safe this new method is and if it can help improve the outcome for older patients with AML.

Key takeaways

A study for older AML patients (60-75) who cannot have standard stem cell transplants.
Investigating 'micro-transplantation' instead of a full transplant.
Aims to find out how safe and effective this new approach is.
You must have already completed initial chemotherapy and be in remission.
Participation involves ongoing monitoring and check-ups.

Who may be eligible?

This study is looking for volunteers who are generally between 60 and 75 years old and have been diagnosed with a specific type of acute myeloid leukaemia (AML). This AML should be of an 'intermediate' or 'adverse' risk type, and you must already be in remission (meaning the cancer has responded well to initial treatment and there are very few or no leukaemia cells visible).

You must also have been told by your doctor that a standard stem cell transplant isn't suitable for you due to other health reasons or potential risks. This study is not for you if you have certain specific types of AML that are known to respond well to other treatments, or if your AML is considered 'standard-risk'.

Lastly, you need to understand what the study involves and be able to give your clear permission to take part. Unfortunately, if you are under a guardianship or can't make your own decisions, you wouldn't be able to join.

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 between 60 and 75 years old?
Have you been diagnosed with acute myeloid leukaemia (AML)?
Has your leukaemia responded well to initial treatment?
Has your doctor told you that a standard stem cell transplant isn't suitable for you?
Are you able to understand the study and give your consent to take part?

Answer every question to see your result.

What does participation involve?

The study involves receiving a 'micro-transplantation' after you have completed your initial chemotherapy for AML. This means you will get cells from a donor who isn't a perfect match. The researchers will be closely monitoring your health, looking at how you react to the treatment, and checking for any side effects. You will have regular check-ups, potentially including blood tests and examinations. The exact number of visits, tests, and the total length of your participation will be explained by the study team. You will be told about all the steps before you agree to take part.

Potential risks and benefits

Participating in this study might offer a potential benefit by giving you a new treatment option if a standard stem cell transplant isn't suitable for you. Researchers hope this 'micro-transplantation' might help control your leukaemia. However, like all medical treatments, there could be risks and side effects, even though this method aims to be gentler than a full transplant. These might include reactions to the donor cells or other health complications. Your doctors will explain all known risks to you. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

CHU Estaing
Verified postcode
Clermont-Ferrand, France· Recruiting
Centre Hospitalier Universitaire de Grenoble
Verified postcode
Grenoble, France· Recruiting
CHRU de Lille
Verified postcode
Lille, France· Not yet recruiting
Centre Hospitalier Lyon Sud
Verified postcode
Lyon, France· Recruiting
Centre Hospitalier Universitaire de Nancy
Verified postcode
Nancy, France· Not yet recruiting
Hôpital de la Pitié-Salpêtrière
Verified postcode
Paris, France· Not yet recruiting
CHU de Saint-Etienne
Verified postcode
Saint-Etienne, France· Recruiting

Common questions

What is 'micro-transplantation'?

It's a treatment where you receive a small number of donor cells to help fight your leukaemia, without the high risks of a full stem cell transplant.

Why is this treatment only for older patients?

It's being studied for older patients (60-75) with AML who can't have standard, more intensive transplants due to health reasons or other risks.

Does this mean I won't need chemotherapy?

No, you will have already completed your initial chemotherapy to treat the AML before having the micro-transplantation.

Who provides the donor cells?

The cells come from a related donor who is not a perfect match. The study team will explain more about this.

What if my leukaemia is a 'standard-risk' type?

This study is specifically for certain 'intermediate' or 'adverse' risk types of AML, so it wouldn't be suitable if you have a 'standard-risk' type.

How to find out more

Jérôme Cornillon, MD

jerome.cornillon@chu-st-etienne.fr 04 77 91 67 26 Official trial record

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