
"I am glad that taking part in a trial might help others on their own cancer journey.”
This trial is comparing with 2 newer combinations of treatment to prevent graft versus host disease (GvHD).
It is for people having a stem cell transplant for certain types of blood cancer.
Graft versus host disease (GvHD) is a possible complication of a from another person. GvHD happens when particular types of white blood cells (T cells) in the donated stem cells or bone marrow attack your own body cells. This is because the donated cells (the graft) see your body cells (the host) as foreign and attack them.
GvHD may affect your skin, gut, liver or mouth. You have a combination of treatment during and after your transplant to prevent it.
We know from research that some newer combinations of treatment may help to reduce the risk of GvHD. But they haven’t been compared to the used in the UK. So the team are running this trial to find out more.
In this trial you have one of the following:
Thymoglobulin, cyclosporin, sirolimus and mycophenolate mofetil (MMF) are all drugs that suppress the . Cyclophosphamide is a chemotherapy drug. It helps prevent the white blood cells from reacting to the transplanted cells. This means that the risk of GvHD is less.
The main aims of the trial are to:
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if you have one of the following types of blood cancer:
To take part in the trial, all of the following must apply. You:
Who can’t take part
You cannot join this trial if any of these apply.
This phase 2 trial is taking place across the UK. The team need to find 400 people to take part.
It is a randomised trial. A computer puts you into a treatment group. Neither you nor your doctor will be able to decide which group you are in. There are 3 treatment groups.
You have one of the following:
Thymoglobulin, cyclosporin and MMF (standard treatment)
You have thymoglobulin as a drip into a vein. You have this over 2 days before and after your transplant.
You have cyclosporin either as a drip into a vein or as capsules you take by mouth. You have the first dose on the day of your stem cell transplant. You continue to take cyclosporin for at least 3 months. Your doctor will tell you when to stop taking this.
You have MMF as a drip or as capsules you take by mouth. You have the first dose the day before your stem cell transplant. You continue to have MMF for at least a month. Your doctor will tell you when you should stop.
Cyclophosphamide, cyclosporin and MMF (new treatment)
You have cyclophosphamide as a drip into a vein over 2 days after your transplant.
You have cyclosporin either as a drip or capsules. You have the first dose 5 days after having your stem cell transplant. You continue to have cyclosporin for at least 3 months. Your doctor will tell you when to stop taking this.
You have MMF as a drip or as capsules. You have the first dose 5 days after your transplant and continue to take it for at least a month. Your doctor will let you know when to stop taking this.
Cyclophosphamide, sirolimus and MMF (new treatment)
You have cyclophosphamide as a drip into a vein over 2 days after your transplant.
You have sirolimus as a tablet or a liquid that you swallow. You have the first dose 5 days after your stem cell transplant. You continue to take sirolimus for at least 3 months.
You have MMF as a drip into a vein or as a capsule that you take by mouth. You have the first dose five days after you have your stem cell transplant. You continue to take MMF for at least a month. Your doctor will tell you when you should stop taking it.
Samples for research
The team ask you to give some extra blood samples. Where possible you give these at the same time as your routine blood tests. The team plan to use the samples to:
Quality of life
The trial team ask you to fill out 3 questionnaires:
The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study. The questionnaires take about 20 minutes to complete.
You have some tests before you have your stem transplant. These are the usual tests you would have even if you weren’t taking part in this trial. These include:
You have your stem cell transplant at the hospital. You stay in hospital on the ward until your doctor thinks you are well enough to go home. They’ll let you know how long you’ll be in hospital for.
You have regular check ups with your doctor after your stem cell transplant. The trial team will monitor you closely for any side effects. They do this for up to 1 year after your transplant. Where possible they will see you when you attend your routine hospital appointments.
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
The common side effects of thymoglobulin are:
The common side effects of cyclosporin include:
Some common side effects of MMF include:
The information sheet about the trial lists all the side effects. The trial doctor will talk to you about all the possible side effects of treatment
While you are taking part in this trial you should tell your doctor what medications you take. This includes over the counter medicines, vitamin supplements and herbal remedies such as St John’s wort. You should also not have grapefruit during the trial.
We have more information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Ronjon Chakraverty
University of Birmingham
IMPACT Partnership
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”