Purpose of trial
The aim of the trial is to see if having extra T cells after a stem cell transplant from an unrelated donor can help the immune system to recover more quickly after the transplant. T cells (or T lymphocytes) are a type of white blood cell that helps fight infection and disease. Normally, when a donor is not a complete tissue type match, doctors remove T cells from the stem cell infusion before they give it to the person being treated. This helps to stop a complication called ‘graft versus host disease’, which can be serious.
Everyone in this trial is due to have a stem cell transplant for lymphoma or another type of blood cancer.
Participants are randomised into 2 groups. You can’t choose which treatment you have and neither can your doctor. You are told which group you are in.
After their transplant, people in group 1 have the standard treatment to prevent graft versus host disease (GvHD).
Those in group 2 have the same standard treatment but they also have their donor’s T cells through a drip into a vein.
There are twice as many people in group 2 as in group 1.
If you are in group 2, you have some of your white blood cells removed about 2 weeks after your transplant. The researchers mix these with your donor’s T cells. You then have the treated T cells intravenously (through a drip into a vein) 3 times, a month apart. If you get GvHD, or your immune system recovers before the end of treatment, you may not have all 3 treatments.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
A total of 24 people are needed for this trial.
You may be able to enter if
- You have been diagnosed with non-Hodgkin lymphoma or Hodgkin lymphoma (people with other types of blood cancer can also be included).
- You are due to have a transplant using stem cells from a donor who is not related to you.
- You are due to have an antibody drug called alemtuzumab as part of your pre-transplant treatment.
- You and your partner are willing to use reliable contraception if there is any chance of you or your partner becoming pregnant.
- You are over 16.
You will not be able to enter if
- You have HIV, hepatitis C or hepatitis B.
- You are pregnant or breastfeeding.
- Your doctor doesn’t think you are well enough to tolerate the study treatment.
More information about this trial is available at the UK Clinical Trials Gateway.