A trial looking at treatment for cytomegalovirus after stem cell or bone marrow transplant (CMV IMPACT)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Blood cancers

Leukaemia

Lymphoma

Myeloma

Non-Hodgkin lymphoma

Status:

Closed

Phase:

Phase 3

This trial is looking at a new treatment called adoptive cellular therapy (ACT) to treat cytomegalovirus (CMV) after a stem cell or bone marrow transplant.

Following a stem cell or bone marrow transplant the system in the body that fights infection (immune system) may not work properly for several months. During this time serious infections may occur that a healthy body is able to control. The most common infection following a transplant is cytomegalovirus.

Cytomegalovirus (CMV) is common and can cause several types of infections. Most people will have had a CMV infection by the time they are adults. It isn’t generally serious. But the virus can remain inactive in the body for many years and cause recurrent infections. This usually only becomes a problem in people who have a very weakened immune systems. For example, it can cause serious chest infections after a stem cell or bone marrow transplant.

If CMV becomes active again following a transplant doctors usually treat it with drugs. Researchers have developed a new way of treating CMV following a transplant. It is called adoptive cellular therapy – ACT. ACT is a way of boosting the immune cells that fight CMV infection.

Laboratory studies Open a glossary item show that ACT can help control CMV after a transplant. The researchers want to find out if ACT can help boost the immune system of people following a stem cell or bone marrow transplant.

There are 2 main ways to boost the immune cells and the researchers want to compare them to see which the best is.

The aims of this trial are to find out

If ACT can help boost the immune system against CMV following a stem cell or bone marrow transplant
Which is the best way to boost the immune cells for ACT

Who can enter

You can enter this trial if you

Are going to have a stem cell or bone marrow transplant and your brother or sister is the donor
Are CMV positive
Have alemtuzumab before your transfusion
Have satisfactory blood test results
At least 18 years old

You cannot enter this trial if you

Are HIV positive
Have a medical condition that could affect you taking part in this trial
Are pregnant or breastfeeding

The researchers would also like to ask your brother or sister to take part in this trial in order to donate cells for ACT. To take part they must be

Well enough to be a donor
CMV positive
At least 16 years old

They cannot enter the trial if they

Have tested positive for syphilis, HIV, hepatitis B or C
Are pregnant or breastfeeding

Trial design

This is a phase 3 trial. This trial will recruit 95 people who are to have a transplant. The trial will also recruit the brother or sister who is the donor.

It is a randomised trial. There are 2 groups. People in group 1 will have adoptive cellular therapy - ACT. People in group 2 will have standard treatment only for CMV. Three out of every five people will be put into group 1. So you have a 3 out of 5 chance of having the experimental treatment in this trial.

ACT is like a second transplant with a certain type of cell. The researchers select the immune cells of your donor with the ability to fight CMV infection. You then have these immune cells that fight CMV through a drip into a vein, like a transfusion.

Everyone will have a physical examination and blood tests 25 days after their transplant.

If you are in the group having ACT, you have it 2 days later.

If you agree to take part in this trial the researchers will ask your permission to store some of the samples they take. The researchers may use these in the future for further research. You can choose not to have your samples stored and still take part in the trial.

Hospital visits

After your transplant you see the doctor for a physical examination and blood tests

Every week for 4 weeks
Every month for 7 months

If you are not in hospital, you attend the outpatient’s department to see the doctor.

If you take part in the trial there are no additional visits as these will be the same as the routine visits after your transplant.

Your brother or sister will need to visit the hospital about 17 days after donating their stem cells or bone marrow. This is to donate the blood cells the researchers use for ACT.