Managing the use of antifungal drugs for blood cancer patients by using blood tests to identify fungal infectio

Not Applicable

Active, not recruiting

Conditions: Fungal infection following treatment for acute myeloid leukaemia (AML), high risk myelodysplasia (HRMDS), and acute lymphoblastic leukaemia (ALL)
Infections and Infestations

Registration Number: ISRCTN11633399

Lead Sponsor: Hull University Teaching Hospitals NHS Trust

Brief Summary: 2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38943201/ (added 01/07/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 404

Inclusion Criteria

Current inclusion criteria as of 26/05/2023:

1. Aged =16 years
2. Diagnosis of new, or relapsed, acute leukaemia or haematological disorder judged to need intensive 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 intensive 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 study

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Previous inclusion criteria:

1. Aged =16 years
2. New diagnosis of, or relapsed, acute myeloid leukaemia (AML; according to WHO classification), acute lymphoblastic leukaemia (ALL), or high-risk myelodysplasic syndrome (HRMDS) judged to need intensive chemotherapy by the patient’s clinical care team
3. The patient is expected to have prolonged neutropenia (=10 days) because of their intensive chemotherapy
4. Patient is willing and able to give informed consent for participation in the study

Exclusion Criteria

Current 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 enrolment
5. Commenced the first cycle of chemotherapy > 72 hours prior to trial enrolment
6. Current diagnosis of prolonged (> 72 hours) neutropenic fever
7. 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 IFI
5. 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 fever
7. 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 fever
4. Pregnancy
5. Planned chemotherapy using a Venetoclax based regimen mandating posaconazole as a concurrent medication

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Antifungal (AF) exposure in the 12 months from recruitment, defined as receipt of =72 hours of therapeutic systemic AF, measured as a dichotomous variable (Yes/No) at 12 months<br>2. Health-related quality of life at 12 months post-randomisation measured using EuroQol 5 Dimensions (5L) Score (EQ-5D-5L) collected at 12 months

Secondary Outcome Measures