CompletedInterventional

Evaluation of a laboratory test called QuantiFERON Cytomegalovirus in allogeneic stem cells transplant patients to assess its ability to detect the timing when the patients' immune system can control cytomegalovirus infection, thus allowing the clinical team the discontinuation of antiviral prophylaxis

This research is investigating a virus called CMV, which can cause serious problems for patients after a stem cell transplant for blood cancers. These patients often have weakened immune systems, making them more likely to get infections like CMV. The study wants to find out if a specific blood test, called QuantiFERON-CMV, can help doctors understand exactly when a patient’s immune system has become strong enough to control the CMV virus. If successful, this could help doctors make better decisions about when it's safe to stop giving patients antiviral medicines after their transplant, potentially reducing side effects and improving care for future patients. Adults receiving a stem cell transplant can participate.

At a glance

Status

Completed

Sponsor

University Hospital Southampton NHS Foundation Trust

Enrolment target

Start

25 Feb 2024

Estimated completion

11 Feb 2025

Cytomegalovirus immune reconstitution in recipients of allogeneic haematopoietic stem cell transplant

What is this study about?

This study is about a virus called Cytomegalovirus, or CMV for short. CMV is a common virus, but it can cause serious illness in people whose immune systems are weak, especially after they've had a stem cell transplant for blood cancer. When you have a stem cell transplant, your immune system needs time to recover, making you vulnerable to infections.

Currently, doctors give antiviral medicines to these patients to prevent CMV from causing harm. But they need a way to know exactly when a patient's own immune system is strong enough to fight off CMV by itself. This study is testing a special blood test called QuantiFERON-CMV. Researchers want to see if this test can tell doctors when your immune system has recovered enough to control the CMV virus. This information could be really helpful.

If this blood test works well, it could help doctors decide the best time to stop giving antiviral medicines. This might mean patients don't have to take these medicines for longer than needed, which could reduce side effects and make their recovery easier. While you won't directly benefit from taking part, your contribution will help doctors improve care for many future patients who undergo stem cell transplants.

Key takeaways

This study evaluates a blood test for CMV in stem cell transplant patients.
The goal is to find when a patient's immune system can control CMV.
This could help doctors decide when to stop antiviral medication.
Participants will have blood drawn seven times over six months.
No direct benefit for participants, but could improve future care.
You can withdraw from the study at any time.

Who may be eligible?

You might be able to take part in this study if you are 18 years old or older and are having a stem cell transplant to treat a blood cancer. There are specific conditions related to the CMV virus that determine if you can join.

Specifically, you need to either have already had CMV yourself (meaning a blood test showed you have CMV antibodies, called CMV IgG positive), or you are receiving stem cells from a donor who has had CMV (meaning your donor is CMV IgG positive). If both you and your donor are negative for CMV, then you wouldn't be able to join this particular 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 18 years old or older?
Are you having a stem cell transplant for a blood cancer?
Have you had CMV yourself (CMV IgG positive)?
OR is your stem cell donor CMV positive?
Are you able to provide your consent to participate?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have a small amount of blood taken a total of seven times over six months. The first blood sample will be taken before your stem cell transplant begins. Afterwards, blood samples will be taken at regular times: around 30, 60, 90, 120, 150, and 180 days after your transplant. The study team will try to take these blood samples during your regular hospital visits or appointments, so you won't have to make extra trips just for the study. These blood samples will help researchers understand how your immune system is recovering and responding to CMV over time.

Potential risks and benefits

There isn't a direct health benefit for you from taking part in this study. However, the information gathered could significantly improve how doctors care for future patients undergoing stem cell transplants by helping them make better decisions about CMV prevention. The main risk involved is the mild discomfort and very small chance of bruising when blood is taken from your arm. The medical team will only take blood samples when it is safe to do so; for example, if your doctor believes taking blood might be harmful, such as if you are anaemic, they will not proceed. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospital Southampton NHS Foundation Trust
City only
Southampton, United Kingdom

Common questions

What is CMV?

CMV (Cytomegalovirus) is a common virus that can cause serious illness in people with weak immune systems, like those who have had a stem cell transplant.

What is a stem cell transplant?

A stem cell transplant is a medical procedure, often used for blood cancers, where healthy stem cells are put into your body to help your immune system recover and make new, healthy blood cells.

Will taking part in this study change my treatment?

No, this study is observing how your immune system recovers. It will not change the medical care or treatments your doctors decide are best for you.

You'll have a small blood sample taken seven times over six months, with the first one before your transplant and the others at regular intervals afterwards.

Who is funding this research?

The study is being funded by expert medical and research groups from Southampton and Bournemouth universities in the UK.

How to find out more

Emanuela Pelosi

Emanuela.Pelosi@uhs.nhs.uk +44 (0)2381205101 Official trial record

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