RecruitingOBSERVATIONAL

Precision Medicine for Stem Cell Transplantation

This study is for patients undergoing a stem cell transplant, a procedure where you receive healthy blood-forming cells from a donor. This helps create a new immune system to fight cancer or replace diseased bone marrow. We're looking for new blood tests that can predict two serious issues that can happen after a transplant: acute Graft-versus-Host Disease (aGvHD) and the cancer returning. aGvHD is when the new cells attack your body, and cancer relapse means the cancer comes back. Being able to predict these problems early means doctors can give you the right treatment sooner, potentially preventing serious illness and improving your chances of a successful recovery. We also want to collect blood samples over time to help future research into stem cell transplants.

At a glance

Status

Recruiting

Sponsor

University of Manchester

Enrolment target

300

Start

06 Jun 2023

Estimated completion

01 Aug 2028

Haematopoietic Stem Cell Transplantation

What is this study about?

When you have a stem cell transplant, you receive healthy cells from a donor. These new cells can create a brand new immune system for you. This is a powerful treatment often used for certain cancers or blood diseases, as it can help fight off cancer or replace unhealthy bone marrow.

However, sometimes things can go wrong. Two serious problems that can happen are called acute Graft-versus-Host Disease (aGvHD) and leukaemia relapse. aGvHD is a condition where the new donor cells see your body as 'foreign' and start to attack it. Leukaemia relapse means that the cancer you were treated for comes back. Both of these can be very dangerous and can unfortunately limit how successful the transplant is.

This study aims to develop new blood tests that can act like early warning signs. If doctors could predict who is likely to get aGvHD or whose leukaemia might come back, they could act much more quickly. This would allow them to adjust your preventative treatments or start new treatments sooner, potentially stopping these serious problems before they become severe. The study will also build up a valuable collection of blood samples from 300 patients over time. This collection will be a huge help for other scientists doing research on stem cell transplants in the future.

Key takeaways

This study aims to develop new blood tests to predict serious transplant complications.
It focuses on predicting Graft-versus-Host Disease and cancer returning.
The goal is to help doctors provide earlier, more personalised treatment.
Participation involves giving extra blood samples over a few months.
The study will also create a valuable collection of samples for future research.

Who may be eligible?

This study is looking for people who are going to have a stem cell transplant where they receive cells from a donor (this is called an allogeneic transplant).

There are no age limits, so children and babies can take part if they are having this type of transplant. You can also join this study even if you are already taking part in another clinical trial.

However, you cannot join if you weigh less than 5 kilograms, or if you are having a different type of stem cell transplant where you receive your own cells back (this is called an autologous transplant).

Quick self-check

Are you having a stem cell transplant where you receive cells from a donor?
Are you able to provide blood samples as required?
Do you weigh at least 5 kilograms?
Are you NOT having a stem cell transplant using your own cells?

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 will have several blood samples taken. The first sample will be taken before your stem cell transplant. Then, more samples will be collected on the day of your transplant, and again on days 7, 14, 21, 28, 56 (which is about 2 months), and 90 (about 3 months) after your transplant.

During this time, if you need a bone marrow sample taken as part of your usual care (this often happens around 100 days after transplant or if your doctors suspect the disease has come back), we would also collect that sample for the study.

If you develop aGvHD and start treatment for it with steroids, an extra blood sample will be taken when that treatment begins. Your doctors will also collect some additional health information from you at these different times. Your participation in the study will last for six months after your transplant.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information we learn could help other patients in the future by improving early detection and treatment of serious complications after stem cell transplants. The main risk involves having extra blood samples taken, which might cause some minor discomfort or bruising. All samples are taken as part of your routine care where possible. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (3)

Manchester Royal Infirmary
Manchester, United Kingdom· Recruiting
Royal Manchester Children's Hospital
Manchester, United Kingdom· Recruiting
The Christie NHS Foundation Trust
Manchester, United Kingdom· Recruiting

Common questions

What is a 'stem cell transplant'?

It's a medical procedure where you receive healthy cells from a donor to help create a new immune system, often used to treat cancers or blood disorders.

What is 'acute Graft-versus-Host Disease' (aGvHD)?

It's a serious problem that can happen after a stem cell transplant where the new donor cells attack your own body.

What is 'leukaemia relapse'?

This means that the leukaemia (type of blood cancer) that was treated comes back after the transplant.

Will taking part in this study affect my usual hospital care?

No, taking part in this study will not affect your standard medical care or treatments for your condition.

How many blood samples will be taken?

You will have several blood samples taken over about three months after your transplant, with potential extra samples if you develop aGvHD or need a routine bone marrow sample.

How to find out more

Mark Williams

mark.williams-4@cruk.manchester.ac.uk +441613063240 Official trial record

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