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Clinical trial Recruiting at 8 sites Interventional Ages 18 and up

Targeted antifungal prevention for patients with acute myeloid leukemia

Official title: PTX3 Genetically Stratified Randomized Double-blinded Allocation Event-driven Clinical Trial for Antifungal Prophylaxis in Patients With Acute Myeloid Leukemia

Run by Centre Hospitalier Universitaire Vaudois · NCT03828773 · Data updated 2026-11-12

This study is testing if a specific antifungal treatment can help patients with acute myeloid leukemia who are getting chemotherapy avoid serious infections.

More Acute Myeloid Leukemia trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment410 (estimated)
SponsorCentre Hospitalier Universitaire Vaudois
Academic / other
Drugs / interventionschemotherapy
Locations9 sites (Ghent, Belgium and 8 other locations)
StatusRecruiting
StartedFebruary 11, 2019
Main results expectedNovember 30, 2027
Study endsNovember 30, 2027
Registry record updatedDecember 9, 2025
Trial IDNCT03828773 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 and older diagnosed with acute myeloid leukemia or myelodysplastic syndrome undergoing intensive chemotherapy.

Probably not a fit

Patients with acute promyelocytic leukemia, those already experiencing neutropenia, or individuals with a history of severe reactions to azole antifungals may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of posaconazole-based antifungal prophylaxis strategies in patients with acute myeloid leukemia (AML) undergoing chemotherapy. It employs a genetically-stratified, randomized, double-blind design to allocate treatment based on the risk of invasive mold infections. The study aims to optimize antifungal use by identifying high-risk patients who would benefit most from broad-spectrum antifungal treatment. The trial is conducted across multiple centers to gather diverse data on patient outcomes.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of invasive mold infections in high-risk AML patients, improving their overall survival rates.

How similar studies have gone: Previous studies have shown promise in using targeted antifungal prophylaxis in similar patient populations, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Signed Informed Consent according to national/local regulations.
2. Age ≥18 years.
3. Diagnosis of Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome in transformation (MDSit) treated with an intensive chemotherapy regimen, including induction / consolidation / salvage remission chemotherapy.
4. Planned hospital admission for the duration of the neutropenic phase (absolute neutrophils count \<500 cells/mm3).

Exclusion Criteria:

1. Patients with neutropenia (absolute neutrophils count\<500 cells/mm3) upon presentation and prior to chemotherapy initiation.
2. Patients with a diagnosis of acute promyelocytic leukemia (APL) or AML-M3.
3. Patients with known history of allergy, hypersensitivity or serious reaction to azole antifungals
4. Women who are pregnant (positive blood/urine pregnancy test within 10 days before randomization) or breast-feeding.
5. Diagnosis and treatment for an Invasive Fungal Infection (IFI) within 3 months prior to study enrolment and an Invasive Mold Infection (IMI) at any point prior to or at the time of enrolment.
6. Severe liver dysfunction, defined as at least one of the following markers: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) or alkaline phosphatase above \>5x upper limit of normality: and/or total bilirubin above \>3x upper limit of normality.
7. Patients with an ECG with a prolonged QTc interval: QTc greater than 450 msec for men and greater than 470 msec for women.
8. Patients who are receiving and cannot discontinue the following drugs at least 24 hours prior to randomization: terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine (because of the possibility of QT prolongation), sirolimus, rifampin, rifabutin, carbamazepine, long-acting barbiturates (e.g., phenobarbital, mephobarbital), ritonavir, efavirenz, or ergot alkaloids (e.g., ergotamine, dihydroergotamine).
9. Serious uncontrolled concomitant disease or comorbidity that, in the opinion of the investigator, may compromise adherence to the study protocol.
10. Receipt of a prior allogeneic Hematopoietic Cell Transplantation (HCT).
11. Previous exposure to mold-active prophylaxis (\>48 hours within 7 days of inclusion).
12. Patients with relapsed leukemia already included in the trial.
13. Patient not affiliated to the French social security system
14. Patient under legal protection (guardianship, curatorship)

Where it's running

  • AZ Sint-Jan Hospital
    Bruges, Belgium     Recruiting
  • University Hospital Leuven (UZ Leuven)
    Leuven, Belgium     Recruiting
  • Henri Mondor Hospital
    Créteil, Île-de-France Region, France     Recruiting
  • Cantonal Hospital Aarau
    Aarau, Aarau, Switzerland     Recruiting
  • University Hospital Basel
    Basel, Basel, Switzerland     Recruiting
  • Cantonal Hospital HFR
    Fribourg, Canton of Fribourg, Switzerland     Recruiting
Show 3 more locations
  • University Hospital of Geneva (HUG)
    Geneva, Canton of Geneva, Switzerland     Recruiting
  • University Hospital of Lausanne / Centre Hospitalier Universitaire Vaudois (CHUV)
    Lausanne, Canton of Vaud, Switzerland     Recruiting
  • Ghent University Hospital
    Ghent, Belgium, Belgium     Terminated

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.