Gene test may help prevent deadly fungal infections in leukemia patients
NCT ID NCT03828773
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a genetic test can help decide which leukemia patients need a strong antifungal drug (posaconazole) to prevent serious mold infections during chemotherapy. About 410 adults with acute myeloid leukemia will be randomly assigned to receive the drug or a placebo, and their genetic risk will be used to guide treatment. The goal is to see if this personalized approach reduces infections without unnecessary side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Posaconazole (Noxafil), an antifungal drug
- What this could lead to
- If successful, this could show that using a genetic test to decide who gets antifungal prevention reduces dangerous mold infections in leukemia patients.
- What could go wrong
- This is an early-stage trial with 410 participants, so results may not apply to all patients. The drug can have side effects like liver issues or drug interactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 410 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2019
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AZ Sint-Jan Hospital
RECRUITINGBruges, 8000, Belgium
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Cantonal Hospital Aarau
RECRUITINGAarau, Aarau, 5001, Switzerland
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Cantonal Hospital HFR
RECRUITINGFribourg, Canton of Fribourg, 1708, Switzerland
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Ghent University Hospital
TERMINATEDGhent, Belgium, 9000, Belgium
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Henri Mondor Hospital
RECRUITINGCréteil, Île-de-France Region, 94010, France
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University Hospital Basel
RECRUITINGBasel, Basel, 4031, Switzerland
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University Hospital Leuven (UZ Leuven)
RECRUITINGLeuven, 3000, Belgium
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University Hospital of Geneva (HUG)
RECRUITINGGeneva, Canton of Geneva, 1211, Switzerland
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University Hospital of Lausanne / Centre Hospitalier Universitaire Vaudois (CHUV)
RECRUITINGLausanne, Canton of Vaud, 1011, Switzerland
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