A trial looking at using azacitidine for people with chronic graft versus host disease (AZTEC)

Cancer type:

Acute leukaemia
Acute lymphoblastic leukaemia (ALL)
Acute myeloid leukaemia (AML)
Blood cancers
High grade lymphoma
Hodgkin lymphoma
Leukaemia
Lymphoma
Myeloma
Non-Hodgkin lymphoma

Status:

Open

Phase:

Phase 2

This trial is for people who are either dependent on steroids, are unable to have steroids or their steroid treatment no longer works. 

More about this trial

Graft versus host disease (GvHD) is a possible complication of high dose cancer treatment. It happens after a bone marrow or stem cell transplant from another person.  

Chronic GvHD (cGvHD) starts more than 100 days after your transplant. It may affect your skin, gut, liver or mouth. But it can also affect other parts of your body, such as your eyes, lungs and joints. Chronic GVHD may be mild or severe, and for some people can go on for several months or even years.

Steroids are commonly used to treat cGvHD. But some people:

  • become dependent on the steroids and their doctors are not able to reduce the dose
  • the steroids do not make the cGvHD any better or they only work for a short time
  • are unable to take steroids

There is no standard treatment Open a glossary item for people in this situation. 

In this trial doctors want to use a chemotherapy drug called azacitidine. It is already used as a treatment for people with

  • myelodysplastic syndrome
  • chronic myelomonocytic leukaemia
  • acute myeloid leukaemia

Research has suggested that it could work for GvHD. Doctors want to see: 

  • if it is a useful treatment for people with cGvHD 
  • how people manage with any side effects

Who can enter

The following bullet points list 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. 

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

  • Have moderate or severe chronic graft versus host disease (cGvHD) and you are dependent on steroids, are unable to have steroids or steroid treatment no longer works
  • Are unable to have treatment with extracorporeal photopheresis (ECP) therapy
  • Have satisfactory blood results
  • Are well enough to be up and about for at least half the day (performance status 0, 1 or 2
  • Are willing to use reliable contraception during treatment and for 3 months afterwards if there is any chance that you or your partner could become pregnant
  • Are aged 16 years or older

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

  • Have cGvHD that only affects your eye (ocular GvHD)
  • Have GvHD in your lungs (pulmonary GvHD)
  • Have had any treatment apart from steroids for your cGvHD within 14 days of starting treatment in the trial
  • Have had any experimental treatment within 14 days of starting treatment in the trial
  • Have had treatment with extracorporeal photopheresis (ECP) therapy in the last 6 months before starting in the trial
  • Have a serious infection that needs treatment
  • Have HIV
  • Have hepatitis B or hepatitis C
  • Have any other serious medical condition or mental health problem that the trial team think could affect you taking part
  • Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. Doctors need up to 35 people to take part. 

You have azacitidine as either an injection just under your skin (a subcutaneous injection) or as an injection into your vein (intravenously). Your doctor will explain which way they think will be best for you. 

You have azacitidine once a day for 5 days (Monday to Friday). 

You have treatment every 4 weeks. Each 4 week period is called a cycle of treatment. You can have up to 6 cycles. 

If test results show that azacitidine is working well, you might have 4 extra cycles. 

Questionnaires
The trial team ask you to complete 2 short questionnaires about your symptoms of GvHD: 

  • once a month during treatment
  • 3 and 6 months after you have finished treatment

They also ask you to complete another questionnaire that looks at how you feel whilst having azacitidine. This is called a quality of life questionnaire. You need to complete it:

  • on the 1st day of each treatment cycle
  • 3 and 6 months after you have finished treatment

Samples for research
To help the doctors learn more about how azacitidine works as a treatment for GvHD you have a blood test 

  • when you join the trial
  • at the end of each cycle of treatment
  • 3 and 6 months after you have finished treatment

They also ask if they can use a sample of tissue (a biopsy Open a glossary item) that has been taken in the past. If you need to have a biopsy of your skin before starting treatment in the trial, the trial team will ask for a sample of this for their research. 

Hospital visits

You see the doctors and have some tests before you start treatment. The tests include:

  • blood tests
  • a physical examination
  • heart trace (ECG Open a glossary item)
  • tests to see how well your lungs work (lung function tests)
  • a walking assessment – you’ll be asked to walk as quickly as you can for 2 minutes

You might also be asked to have a sample of your GvHD taken (a biopsy). You only have this if your doctor thinks it is necessary. 

You go to hospital once a day Monday to Friday for your treatment. Your visit should last 1 to 2 hours. You should not need to stay overnight. 

You see the doctors during treatment and have regular blood tests and physical examinations. 

You have lung function tests every 3 months. 

After you have completed all your treatment you see the doctors at:

  • 3 months
  • 6 months

Side effects

The trial team will monitor you during the time you have treatment and you will be given a phone number to call them if you are worried about anything.

The most common side effects of azacitidine are:

  • a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness 
  • feeling or being sick    
  • diarrhoea
  • constipation 
  • tiredness (fatigue)
  • high temperature (fever)
  • sore throat with swelling or pain in your nose or the lining of your nose (nasal membranes)
  • tummy (stomach) pain
  • pain- this can be in your chest, muscles or joints
  • shortness of breath
  • loss of appetite
  • skin rash 
  • itchiness
  • bruising
  • a reaction at the place where you have the injection or drug into your vein- this can include itching, pain, redness, bleeding, bruising, swelling or tissue damage

The doctors will explain all the possible side effects to you before you start the trial. 

We have more information about azactidine.

Location

Birmingham
Bristol
London
Manchester

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

Dr Ram Malladi

Supported by

Bloodwise
NIHR Clinical Research Network: Cancer
University of Birmingham

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12132

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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