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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Samantha
Brady
+44 (0)1904 321926
biodrive-group@york.ac.uk
Dr
Gavin
Barlow
+44 (0)7979653817
gavin.barlow@york.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Fungal infection following treatment for acute myeloid leukaemia (AML), high risk myelodysplasia (HRMDS), and acute lymphoblastic leukaemia (ALL)
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Acute myeloid leukaemia (AML), high risk myelodysplasia (HRMDS), and acute lymphoblastic leukaemia (ALL) are blood cancers treated by chemotherapy. Prolonged fever is common during chemotherapy and can be due to a fungal infection. This may be life-threatening and is difficult to diagnose. Antifungal drugs are often given as a preventive. Antifungals have side effects and overuse may lead to infections that are resistant to them. Alternatively, blood tests can be used to detect fungal infections before symptoms start.
The aim of this study is to determine if fewer antifungals are used in patients having regular blood tests compared to preventative antifungal drugs, without decreasing quality of life.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38943201/ (added 01/07/2024)
You can take part if:
Current inclusion criteria as of 26/02/2025:
1. Aged ≥16 years
2. Diagnosis of new, or relapsed, acute leukaemia or haematological disorder judged to need chemotherapy by the patient’s clinical care team. Eligible conditions include acute myeloid leukaemia (AML), acute lymphoblastic leukaemia (ALL), high-risk myelodysplastic syndrome (HRMDS), or AML transformation of a myeloproliferative neoplasm (tMPN).
3. The patient is expected to have prolonged neutropenia related to chemotherapy which would mandate either antifungal prophylaxis and/or systematic invasive fungal infection biomarker monitoring (at least weekly).
4. Patient is willing and able to give informed consent for participation in the
You may not be able to take part if:
Current exclusion criteria as of 26/02/2025:
1. Previous proven or probable invasive fungal infection (IFI) (according to the EORTC/MSG criteria). (I.e. this would not include previously treated cutaneous or other non-invasive infection, etc. If there is doubt about eligibility, please discuss with the local PI / research team and, if required, the central trial team / Chief Investigators).2. Contraindication to all potential prophylactic antifungal agents (i.e. cannot be prescribed any recognised anti-Aspergillus agent as prophylaxis)3. Planned chemotherapy using any regimen that mandates the use of systemic antifungal medication4. Received > 72 hours of systemic mould-acting antifungal prophylaxis or therapy, or biomarker monitoring for IFI, prior to trial enrolment5. Commenced the first cycle of chemotherapy > 72 hours prior to trial enrolment6. Current diagnosis of prolonged (> 72 hours) neutropenic fever7. Pregnancy
_____
Previous exclusion criteria as of 24/04/2024:
1. Previous proven or probable invasive fungal infection (IFI) (according to the EORTC/MSG criteria). (I.e. this would not include previously treated cutaneous or other non-invasive infection, etc. If there is doubt about eligibility, please discuss with the local PI/research team and, if required, the central trial team / Chief Investigators).2. Contraindication to all potential prophylactic antifungal agents (i.e. cannot be prescribed any recognised anti-Aspergillus agent as prophylaxis)3. Planned chemotherapy using any regimen that mandates the use of systemic antifungal medication (i.e.Venetoclax-based regimens)4. Received > 72 hours of systemic mould-acting antifungal prophylaxis or therapy, or biomarker monitoring for IFI, prior to trial enrolment5. Commenced the first cycle of chemotherapy > 72 hours prior to trial enrolment6. Current diagnosis of prolonged (> 72 hours) neutropenic fever7. Pregnancy
_____
Previous exclusion criteria as of 26/05/2023:
1. Previous proven or probable invasive fungal infection (IFI)2. Contraindication to all potential prophylactic antifungal agents (i.e. cannot be prescribed any recognised anti-Aspergillus agent as prophylaxis)3. Planned chemotherapy using any regimen that mandates the use of systemic antifungal medication (i.e.Venetoclax-based regimens)4. Commenced antifungal prophylaxis or biomarker monitoring for IFI5. Commenced the first cycle of chemotherapy AND has entered the invasive fungal infection (IFI) at risk period according to the usual local standard of care (i.e. the period that normally mandates local IFIpreventi on measures such as antifungal prophylaxis and/or biomarker monitoring)6. Current diagnosis of neutropenic fever7. Pregnancy
Previous exclusion criteria:1. Previous proven or probable invasive fungal infection (IFI)2. Contraindication to all potential prophylactic antifungal agents (i.e. cannot be prescribed any recognised anti-Aspergillus agent)3. Current diagnosis of chemotherapy-related neutropenic fever4. Pregnancy5. Planned chemotherapy using a Venetoclax based regimen mandating posaconazole as a concurrent medication
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Gavin
Barlow
+44 (0)7979653817
gavin.barlow@york.ac.uk
Dr
Samantha
Brady
+44 (0)1904 321926
biodrive-group@york.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by Hull University Teaching Hospitals NHS Trust and funded by National Institute for Health Research.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 52545
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
