A trial looking at a treatment to improve immunity after a stem cell transplant for leukaemia, lymphoma or myeloma (ICAT)

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

Cancer type:

Acute leukaemia

Acute lymphoblastic leukaemia (ALL)

Acute myeloid leukaemia (AML)

Blood cancers

Chronic leukaemia

Chronic lymphocytic leukaemia (CLL)

Chronic myeloid leukaemia (CML)

Hodgkin lymphoma

Leukaemia

Lymphoma

Myelodysplastic syndrome (MDS)

Myeloma

Non-Hodgkin lymphoma

Status:

Closed

Phase:

Phase 2

This trial is looking at a way of helping your immune system to recover after having a stem cell transplant using cells from an unrelated donor. It is for people with one of the following cancers

Or a condition called myelodysplastic syndrome (MDS)

More about this trial

Doctors can treat these cancers and some types of MDS with chemotherapy, followed by a stem cell transplant using cells from a donor. After a stem cell transplant, your immune system, which normally protects your body from infection, won’t work properly for several months.

When you have a stem cell transplant, immune cells called T cells are removed from your donor’s cells. This is done to try to stop your donor’s T cells attacking your body tissues causing a complication called graft versus host disease (GVHD).

GVHD can affect your skin, digestive system Open a glossary item and other body organs. Removing most of the immune cells from your donor’s cells reduces the risk of GVHD, but it also affects other immune cells that help you fight infection.

In this trial, researchers are looking at a way of giving you T cells from your donor to help fight infection, after they have removed the ones that cause GVHD. These are called allodepleted T cells. To make allodepleted T cells, the researchers mix some of your own white blood cells with some cells from your donor. They can then give you these cells at intervals after your stem cell transplant.

A similar approach has been used to treat children having a stem cell transplant and adults having a transplant using cells from a brother or sister. Researchers now want to see if it could help adults having a transplant using cells from an unrelated donor.

The aim of the trial is to see if having allodepleted T cells helps your immune system to recover more quickly without increasing your risk of GVHD.

Who can enter

You may be able to join this trial if all of the following apply. You have one of the following cancers

Or a condition called myelodysplastic syndrome (MDS)

And you

Are going to have a stem cell transplant using cells from an unrelated donor
Are at least 16 years old
Are willing to use reliable contraception during the trial and for a year afterwards if there is any chance you or your partner could become pregnant

You cannot join this trial if any of these apply. You

Are not well enough to join
Are HIV, hepatitis B or hepatitis C positive before your transplant
Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The researchers need 24 people to be treated.

It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

People in one group have a stem cell transplant using cells from a donor, followed by the standard treatment Open a glossary item to prevent graft versus host disease. Doctors have found enough people to join this group. So, this group is now closed.

Everyone who joins the trial now has a stem cell transplant, the standard treatment to prevent graft versus host disease, and allodepleted T cells up to 3 times after their transplant.

There will be twice as many people in the group having allodepleted T cells as in the group having standard treatment alone.

ICAT trial diagram

People in both groups will have a tube put into a large vein in their chest before they start treatment. This may be a central line or a PICC line.

Whichever group you are in, you have medication to prevent GVHD after your transplant. This medication reduces over time. But if you do develop GVHD, your doctors will stop reducing this medication and treat the disease.

If you are in the group having allodepleted T cells, the researchers will remove some of your own white blood cells about 2 weeks before your transplant. They do this by taking blood from your central line or PICC line and passing it through a machine that separates out the white blood cells. The rest of your blood cells are then returned to you through your line.

In the laboratory, the researchers mix your white blood cells with some immune cells from your donor to create allodepleted T cells.

After your transplant, you have these cells back through a drip into your central line or PICC line. It takes 5 minutes each time. As long as you are well enough, you have the allodepleted T cells 1 month, 2 months and 3 months after your stem cell transplant.

If you develop GVHD or your immune system gets back to normal within the first 3 months, you may not have all 3 doses.

Hospital visits

You see the trial team and have some blood tests before you take part in the trial.

You will be in hospital for quite a while when you have your stem cell transplant. And when you go home, you will need to go back for regular hospital appointments. Your doctor will explain this to you.

Whichever group you are in, you will see the trial team and have blood tests once a month until a year after your transplant.

Side effects

As the researchers are using a new technique to create allodepleted T cells, there may be side effects they don’t know about yet. Possible side effects include allergic reactions causing problems such as high temperature, rash, shivers, difficulty breathing and low blood pressure.

The trial team will give you medication to try to prevent side effects and they will monitor you very closely for at least 4 hours each time you have the allodepleted T cells. If you do have any side effects, they will give you medication to treat them and continue to monitor you until the symptoms improve.

You may have side effects from the stem cell transplant itself. Your doctor will talk to you about all the possible side effect before you agree to join the trial.

If you become unwell between hospital visits, you must phone the team immediately for advice. When you join the trial, your doctor or nurse will give you a card with the correct number to call. You should carry this card with you at all times.

We have more information about the side effects of stem cell transplants.