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 mycophenolate mofetil (MMF)
- cyclophosphamide, cyclosporin and MMF
- cyclophosphamide, sirolimus and MMF
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:
- see how treatment affects the immune system
- look for substances called biomarkers to predict who might develop GvHD
Quality of life
The trial team ask you to fill out 3 questionnaires:
- before your transplant and then at
- 6 months and 12 months after your transplant
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.
