A trial looking at a blood test to reduce the use of fungal medication for certain blood cancers (BioDriveAFS)
Cancer type:
Status:
Phase:
This trial is looking at blood tests to check for signs of a fungal infection before giving an anti fungal medication. It is comparing this to the usual way of having medication to prevent a fungal infection developing.
It is for people who are having 
for one of the following types of blood cancer:
- acute myeloid leukaemia
- high risk myelodysplastic syndrome
- acute lymphoblastic leukaemia
- myeloproliferative neoplasms that have changed to acute myeloid leukaemia
More about this trial
The standard treatment for people with acute myeloid leukaemia (AML), high risk myelodysplastic syndrome (MDS) and acute lymphoblastic leukaemia (ALL) includes high dose chemotherapy. People who have low levels of after their chemotherapy are at higher risk of infections, including fungal infections.
Fungal infections include a type of lung infection called aspergillosis. And another type of common fungal infection called candidiasis. You may hear this called . These infections are difficult to diagnose and treat and can make people very unwell.
To reduce the risk of getting a fungal infection you usually have regular anti fungal medication during chemotherapy. This is called preventative therapy.
There are concerns about a rise in anti fungal resistance. This is because a lot of people take these drugs to prevent a small total number of fungal infections. So researchers are looking at ways to reduce the number of people who have preventative therapy for a fungal infection.
To do this, they are looking at a blood test. It is already used in the NHS. This checks for signs of a fungal infection. It could work out more precisely when fungal treatment needs to be started.
In this trial, some people have anti fungal medication to prevent an infection as usual. And some have regular blood tests to monitor for signs of fungal infection. They only start anti fungals if they develop an infection.
The main aims of the trial are to find out:
- the barriers to doing this trial and what specific factors help the researchers to run this trial
- if it is possible that the blood test can reduce the use of anti fungal medication without affecting
quality of life or increasing fungal infections - more about the cost
Please note, you might not benefit directly from taking part in this trial. It might help to reduce the use of anti fungal medications in the future.
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 all of the following apply. You:
- have certain types of newly diagnosed blood cancer or the cancer has come back after treatment. These cancer types include acute myeloid leukaemia (AML), acute lymphoblastic leukaemia (ALL), myelodysplastic syndrome that has a high risk of developing into AML or you have myeloproliferative neoplasm that has developed into AML. Your doctor will know this.
- need to have
high dose chemotherapy - are expected to have a drop in the number of
white blood cells caused by the chemotherapy. This means you need to have preventative anti fungal medication, testing for an invasive fungal infection, or both. - are at least 16 years old
Who can’t take part
You cannot join this trial if any of these apply. You:
- have a fungal infection or you might have one. You can take part if you had a fungal skin infection or another fungal infection that didn't affected the whole body and was treated.
- can’t have anti fungal drugs to prevent a fungal infection for any reason
- are having a type of chemotherapy that already includes the use of an anti fungal medication to the whole body. Your doctor will know this.
- have had more than 72 hours of biomarker monitoring for a fungal infection. Your doctor will know this
- start the first
cycle of chemotherapy more than 72 hours (3 days) before joining the trial - currently have a temperature (fever) with a low number of white blood cells and you have had this for more than 72 hours
- are pregnant
Trial design
This phase 3 trial is taking place in the UK. The team need 404 people to take part.
It is a randomised trial. A computer puts you into a treatment group. Neither you nor your doctor can decide which group you are in.
You have one of the following:
- preventative anti fungal medication
- regular blood tests to check for a fungal infection
Preventative anti fungal (group 1)
Your doctor will decide which anti fungal medication you will have. They can tell you more about this and how often you’ll have it.
Regular blood tests for fungal infection (group 2)
You don’t start anti fungal medication straight away.
You have blood tests to monitor for a fungal infection twice a week while you are having chemotherapy. These blood tests check for 2 called galactomannan and beta-D-glucan. These detect signs of a fungal infection. You have these blood samples taken at the same time as your other routine blood tests.
You have further tests if you test positive for a fungal infection. Or if you become ill and your doctor suspects you have a fungal infection. These might include a type of CT scan called a high resolution computed tomography and a bronchoscopy. You then start an anti fungal medication if a fungal infection is likely.
Quality of life
The trial team ask everyone in the trial to fill out some questionnaires:
- at the start of the trial
- at 3 months
- at 6 months
- at 12 months
The questionnaires ask about your health and how you’ve been feeling
This is called a quality of life study. You will be sent a link to complete the questionnaires online. Or a member of the trial team can help you complete the questionnaire over the telephone. A paper copy could be posted to you if you prefer. The questionnaires take around five to ten minutes to fill in.
Other information collected
The hospital will also send the trial team information about how many anti fungal medications you have had and if you did or didn’t have a fungal infection. The team also collect results of blood tests, and what has happened to you during your treatment and recovery.
Hospital visits
You won’t have extra hospital visits for this trial. This is because you will have a long hospital stay to have your high dose chemotherapy. So you’ll already be in the hospital when you join the trial.
Side effects
Having preventative anti fungal drugs or regular monitoring using blood tests are already used in the NHS. Based on current evidence, the team don’t think there is a higher risk for either group.
All medication including anti fungals have risks and side effects and may affect other medicines that you are taking. You will be monitored for side effects if you are taking anti fungal medication. If you are already taking them, it may also be more difficult to detect a fungal infection if you do develop one.
It is also possible that the blood tests for fungal infections will not detect a fungal infection when you do actually have one. This could delay treatment.
The trial doctor can recommend anti fungal treatment at any point during the trial. This is if they think you need treatment and this is the best thing for you.
The trial doctor will talk to you about the pros and cons of joining this trial. They will answer any questions you may have.
Location
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.
Chief Investigator
Professor Gavin David Barlow
Professor David Allsup
Supported by
National Institute for Health Research Health Technology Assessment programme
Hull University Teaching Hospitals NHS Trust
University of York
Hull York Medical School
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
