A trial looking at a different way of giving posaconazole to prevent fungal infection after treatment for some blood cancers

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Acute leukaemia
Acute myeloid leukaemia (AML)
Blood cancers
Chronic leukaemia
Chronic myeloid leukaemia (CML)
Leukaemia
Myelodysplastic syndrome (MDS)

Status:

Closed

Phase:

Phase 1

This trial is looking at giving posaconazole in a different way to prevent fungal infection after treatment for acute myeloid leukaemia (AML), myelodysplastic syndrome (MDS) and chronic myeloid leukaemia (CML).  

Doctors can treat AML, MDS and CML with chemotherapy or a bone marrow or stem cell transplant. One of the side effects of both these treatments is a drop in white blood cells causing an increased risk of infection, including fungal infection.

Posaconazole is a drug that doctors use to treat or prevent fungal infection.  It is a liquid that you swallow.  The researchers have developed another form of posaconazole that you have as a drip into a vein.  The researchers want to measure the level of posaconazole in the blood after having it through a drip.  They will do this by taking blood samples.

The aims of this trial are to find out the

  • Levels of posaconazole in the blood before and after having it through a drip
  • Side effects of having posaconazole through a drip
  • Levels of posaconazole in the blood after switching from having it as a drip to a liquid that is swallowed

Who can enter

You may be able to enter this trial if you

You cannot enter this trial if you

  • Have had treatment for fungal infection, or possible fungal infection, in the last month, apart from a cream or a mouthwash
  • Have taken posaconazole as part of another clinical trial in the last 3 months
  • Are sensitive to drugs similar to posaconazole such as ketaconazole, fluconazole or itraconazole
  • Are taking other medications that could affect how posaconazole works
  • Have any other medical condition that could affect you taking part in this trial
  • Are pregnant or breastfeeding

Trial design

This is a phase 1 trial.  It will recruit 200 people from different countries around the world.

Everyone taking part in this trial will have posaconazole.  For the first 5 days everyone will have posaconazole as a drip into a vein.  On the first day, you have it twice.  And for the next 4 days, you have it once a day.  You will be in hospital for these 5 days.  After this you take posaconazole as a liquid to swallow.

For this part of the trial you will be put into 1 of 2 groups by a computer.  Neither you nor your doctor can choose which group you are in.  This is called a randomised trial.

People in group 1 will take the posaconazole liquid twice a day.

People in group 2 will take the posaconazole liquid 3 times a day.

You take the posaconazole liquid at the same time each day, about 10 minutes after a meal or a build up drink that replaces a meal.  You have a diary to record the exact time and date you take the posaconazole.

If after starting the posaconazole liquid you find you are not able to continue taking it, you will go back to having it as a drip into a vein.

You continue to take the posaconazole liquid for another 13 days.  You will stop taking it earlier if you recover from graft versus host disease or your white blood cell count recovers.

As a part of this trial the researchers will take blood samples on a number of occasions before you have posaconazole.  This is to measure how much of it is in your blood.

Hospital visits

You see the doctor before starting treatment and have some tests.  These may include

  • A physical examination
  • Assessment for signs and symptoms of a fungal infection
  • Blood tests
  • Heart trace  (ECG)

You will be in hospital for 5 days when you start posaconazole.

After leaving hospital, you see the doctor 2 days later and then weekly for 2 weeks.

At these appointments you may have

  • A physical examination
  • A check for signs and symptoms of a fungal infection
  • Blood tests

You see the doctor about 2 months later to see how you are.

Side effects

The most common side effects of posaconazole may include

  • Diarrhoea
  • Feeling or being sick
  • Tiredness
  • Loss of appetite
  • Rash, dry or itchy skin
  • Feeing weak, muscle pain
  • Feeling sleepy or difficulty getting to sleep
  • Taste changes
  • Constipation
  • Feeling bloated, wind (flatulence)
  • A drop in blood cells causing an increased risk of infection, bruising and bleeding
  • Fever
  • Dizziness
  • Headache
  • Dry mouth
  • Tummy (abdominal) pain
  • Indigestion
  • Back pain
  • Liver changes

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 Samir Agrawal

Supported by

Merck
Sharp & Dohme
Schering Plough Research Institute

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 9215

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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