"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at different combinations of drugs before a stem cell transplant for acute myeloid leukaemia or myelodysplastic syndrome (FIGARO)
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Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a new combination of drugs that you have before a stem cell transplant for acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS).
More about this trial
To reduce side effects from high dose treatment, doctors may use lower doses of drugs. This is called reduced intensity conditioning.
But there is a risk that AML or MDS may come back (relapse) after reduced intensity conditioning. So researchers are looking for new combinations of drugs to reduce the risk of the disease coming back without increasing side effects.
In this trial, they are looking at a combination of drugs called FLAMSA-BU. It is made up of the chemotherapy drugs fludarabine, cytarabine, amsacrine and busulphan, as well as 2 drugs called ATG and mycophenolate mofetil that damp down your immune system.
Everybody taking part in this trial has AML or MDS and their doctors think there is a high risk of it coming back after treatment. Everyone will have reduced intensity conditioning. Some will have FLAMSA-BU before having a stem cell transplant. Some will have 1 of 3 other conditioning treatments currently used in the UK.
The aim of the trial is to see how people who have FLAMSA-BU get on after their transplant compared to people who have other types of conditioning treatment.
Who can enter
You may be able to enter this trial if you
- Have acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS)
- Have a suitable matched donor and are going to have a reduced intensity stem cell transplant – your doctor can advise you about this
- Are at least 16 years old
- Have satisfactory results from tests that check how well your heart, lungs, liver and kidneys are working
- Have recovered from the side effects of any other treatment
- 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 from the beginning of treatment until 6 months after your transplant if there is any chance you or your partner could become pregnant
You cannot enter this trial if you
- Have AML or MDS that has come back and now isn’t responding to chemotherapy
- Can’t have a stem cell transplant with reduced intensity conditioning for any reason
- Have heart disease that causes symptoms – the trial doctor can advise you about this
- Have an infection that needs treatment
- Have another type of cancer as well as having AML or MDS
- Are known to be HIV positive or have hepatitis A, B or C
- Are pregnant or breastfeeding
This phase 2 trial will recruit about 240 people. 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.
Everybody taking part has a stem cell transplant using cells from a donor. Half the people taking part will have FLAMSA-BU conditioning before their transplant. The other half will have 1 of the following
- Fludarabine, melphalan and alemtuzumab (FMA)
- Fludarabine, busulphan and alemtuzumab (FBA)
- Fludarabine, busulphan and ATG (FB-ATG)
Whichever treatment you are having, you have all the drugs through a drip into a vein. If you have FLAMSA-BU, you will have treatment over about 12 days. If you have one of the other drug combinations, you will have treatment for either 5 or 7 days. You then have your stem cell transplant.
Everybody in the trial also has a drug called ciclosporin for about 3 months after their transplant. It helps to stop your immune system rejecting the transplanted stem cells.
The trial team will ask you to fill out a questionnaire before you start treatment, then 6 weeks, 3 months, 6 months, 9 months, 1 year, 18 months and 2 years after your transplant. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- Bone marrow test
You will be hospital for between 4 and 6 weeks to have your conditioning and stem cell transplant.
When you are in hospital, you have regular blood tests. Once you go home, you see the trial team and have more blood tests 6 weeks after your transplant and then every 3 months for 2 years. You may need to have blood tests more often than this.
You have another bone marrow test after 6 weeks and then every 3 months until a year after your transplant.
The most common side effects of a stem cell transplant include
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Feeling or being sick
- Sore mouth
The trial team will give you more information about the possible side effects of all the individual drugs before you agree to take part in the trial. We have more information about the side effects of stem cell transplants.
How to join a clinical trial
Professor Charles Craddock
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Birmingham