A trial of treatment to prevent GvHD after a stem cell transplant (MoTD)

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)
Myelofibrosis
Myeloma
Non-Hodgkin lymphoma

Status:

Open

Phase:

Phase 2

This trial is comparing standard treatment  Open a glossary itemwith 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.

More about this trial

Graft versus host disease (GvHD) is a possible complication of a stem cell transplant Open a glossary item 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 standard treatments Open a glossary item 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 and mycophenolate mofetil (MMF). This is a standard treatment. 
  • cyclophosphamide, cyclosporin and MMF. This is a newer treatment.  
  • cyclophosphamide, sirolimus and MMF. This is a newer treatment.

Thymoglobulin, cyclosporin, sirolimus and mycophenolate mofetil (MMF) are all drugs that suppress the immune system Open a glossary item. 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:

  • compare the standard treatment with 2 newer combinations of treatment to see how well they work
  • see who goes on to develop GvHD
  • learn more about the side effects of treatment
  • see how treatment affects quality of life

Who can enter

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:

  • are going to have a stem cell transplant Open a glossary item using someone else’s cells (allogeneic transplant Open a glossary item)
  • have a suitable donor arranged for the stem cell transplant 
  • are due to have lower doses of chemotherapy (reduced intensity conditioning). You must have chemotherapy that includes fludarabine and melphalan, a combination of chemotherapy called BEAM or LEAM, fludarabine and busulphan or fludarabine and treosulfan. Your doctor will know about this. 
  • have satisfactory blood test results 
  • are willing to use reliable contraception during the trial and for a period after if there is any chance you or your partner could become pregnant 
  • are between 16 and 70 years of age 

Who can’t take part

You cannot join this trial if any of these apply. 

  • Your doctor is going to change the stem cells in some way. Your doctor can tell you more about this. 
  • You are going to have a drug called alemtuzumab or any method of lowering the number of T cells Open a glossary item apart from certain ones. Your doctor will know this. 
  • You are taking part in another clinical trial called COSI or ALL-RIC.
  • You have a medical condition such as heart problems Open a glossary item, lung problems Open a glossary item, kidney problems or any other condition that could affect you taking part in the trial. Your doctor checks this before you join the trial. 
  • You have an active hepatitis B or hepatitis C infection.
  • You are sensitive to any of the drugs used in the trial or anything that they contain. Or you can’t have any of the trial treatments for any other reason.
  • You are pregnant or breastfeeding.

Trial design

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 Open a glossary item 
  • look for substances called biomarkers Open a glossary item 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.

Hospital visits

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:

  • a physical examination Open a glossary item
  • blood tests
  • urine tests 
  • bone marrow test or having a sample of cancer tissue (biopsy Open a glossary item) taken 

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.

Side effects

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:

  • seizures (fits)
  • liver problems Open a glossary item
  • headache
  • kidney problems
  • high blood pressure
  • high level of sugar in your blood
  • tiredness (fatigue)
  • tummy pain
  • excess growth of body hair
  • acne
  • hot flushes
  • fever
  • a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • feeling numb or tingling
  • pain in your muscles
  • stomach ulcer
  • swollen gums 

Some common side effects of MMF include:

  • feeling or being sick
  • diarrhoea
  • fever or chills
  • change in blood pressure
  • skin rash
  • fast heartbeat
  • cough, shortness of breath
  • fluid on the lungs
  • feeling anxious or depressed
  • difficulty sleeping
  • confusion
  • feeling dizzy, drowsy or numb
  • tremor, muscle spasms and headache
  • changes to liver and kidney blood tests 
  • a drop in blood counts causing an increased risk of infection, tiredness or bruising 
  • fits (seizures)
  • skin cancer
  • liver problems 
  • acne
  • hair loss
  • muscle weakness
  • swelling of the gums and mouth ulcers
  • feeling bloated
  • weight loss

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:

Location

Birmingham
Bristol
Cambridge
Cardiff
Glasgow
Leeds
London
Manchester
Newcastle Under Lyme
Newcastle upon Tyne
Nottingham
Oxford
Plymouth

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Ronjon Chakraverty

Supported by

University of Birmingham
IMPACT Partnership

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

18058

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Last reviewed:

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