ICAT: a phase 2 trial to see if specially treated T cells can help the immune system to recover after a stem cell transplant for lymphoma

This summary is for people with lymphoma but people with other types of blood cancer may be able to enter this trial.


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.


Treatments

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.

Further information

More information about this trial is available at the UK Clinical Trials Gateway