Active not recruitingPHASE2INTERVENTIONAL

Early Prophylactic Donor Lymphocyte Infusion After Allo-HSCT for Patients With AML

This study is investigating if an extra treatment, called a donor lymphocyte infusion (DLI), given early after a stem cell transplant, can help prevent acute myeloid leukaemia (AML) from returning. A stem cell transplant is a good way to treat AML, but unfortunately, the leukaemia can sometimes come back. DLI uses special immune cells from the original stem cell donor to help fight off any remaining cancer cells. While DLI has been used when AML comes back, we don't know much about giving it early to try and stop it from happening in the first place. This study aims to find out if giving DLI early can improve the chances of staying cancer-free after a stem cell transplant.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Institut Paoli-Calmettes

Enrolment target

124

Start

07 Sep 2020

Estimated completion

01 May 2028

Acute Myeloid Leukemia

What is this study about?

Acute myeloid leukaemia (AML) is a type of blood cancer. One very effective treatment for AML is a stem cell transplant, where healthy stem cells from a donor are given to replace the patient's own. While this can be life-saving, one of the biggest challenges is that the leukaemia can sometimes return after the transplant.

This study is looking at a specific treatment called a donor lymphocyte infusion (DLI). DLI involves giving a small amount of white blood cells, called lymphocytes, from the original stem cell donor to the patient. These donor cells are like soldiers of the immune system and can help find and destroy any leukaemia cells that might still be present after the transplant, ideally stopping the cancer from growing back.

While DLI has been used for many years when AML has unfortunately returned after a transplant, we don't yet have strong evidence on whether giving it *early* to simply prevent the leukaemia from coming back is helpful. This research aims to understand if giving DLI soon after a stem cell transplant can be an effective way to keep AML in remission for longer. It's a new approach to try and give patients the best possible outcome.

Key takeaways

This study investigates an extra treatment called DLI for AML patients after a stem cell transplant.
The goal is to see if giving DLI early helps stop the leukaemia from returning.
AML must be in remission to join, and you must be 18-70 years old.
DLI uses immune cells from your donor to fight any remaining cancer cells.
Participation involves receiving DLI and regular check-ups to monitor your health.
There's a potential benefit of staying cancer-free longer, but also risks like GVHD.

Who may be eligible?

To join this study, you would need to be between 18 and 70 years old. You must have acute myeloid leukaemia (AML) but currently be in remission, meaning your leukaemia is not active at the time you join. You will also have had a stem cell transplant from a donor, but not a cord blood transplant.

There are also some important things that would mean you couldn't take part. For example, if you have had certain serious side effects from your transplant, like severe graft-versus-host disease (GVHD), you wouldn't be able to join. Your doctors will also check that you don't have other serious health problems that would make it unsafe for you to be part of 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.

Are you between 18 and 70 years old?
Do you have acute myeloid leukaemia (AML) that is currently in remission?
Have you had a stem cell transplant (not from cord blood)?
Are you currently taking cyclosporine A to prevent graft-versus-host disease (GVHD)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the early donor lymphocyte infusion (DLI) treatment. Your doctors will explain the exact schedule for this. You would also have regular appointments to monitor your health closely, including blood tests and other assessments, to see how you are responding to the treatment and to check for any side effects. The study will continue to follow your health and progress over time. The total length of your participation, including follow-up, will be explained by the study team.

Potential risks and benefits

Participating in this study might offer the potential benefit of reducing the chance of your AML returning after your stem cell transplant. However, all medical treatments carry risks, and DLI can have side effects, including a condition called graft-versus-host disease (GVHD), where the donor cells attack healthy tissues. Your study doctor will discuss all potential side effects and benefits with you in detail. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time without it affecting your future medical care.

Locations (1)

Institut Paoli-Calmettes
Verified postcode
Marseille, France

Common questions

What is acute myeloid leukaemia (AML)?

AML is a type of cancer that starts in the blood-forming cells of the bone marrow. It usually progresses quickly.

What is a stem cell transplant?

It's a treatment where unhealthy blood cells are replaced with healthy cells from a donor.

What is a donor lymphocyte infusion (DLI)?

DLI is when you receive immune cells from your original stem cell donor, which can help fight off any remaining cancer cells.

Why is this study looking at 'early' DLI?

We are trying to find out if giving DLI soon after a transplant can prevent the leukaemia from coming back, rather than waiting until it has already returned.

Will I still get my usual treatment for graft-versus-host disease (GVHD)?

Yes, you will continue with your standard GVHD prevention medicine (cyclosporine A) as part of this study.