Clinical trial · Interventional
PTX3-targeted Antifungal Prophylaxis
PTX3 Genetically Stratified Randomized Double-blinded Allocation Event-driven Clinical Trial for Antifungal Prophylaxis in Patients With Acute Myeloid Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective genetically-stratified randomized double-blind event-driven multicentre clinical trial to assess the efficacy of posaconazole-based antifungal prophylaxis allocation strategies for patients with acute myeloid leukemia who receive induction chemotherapy. Allocation strategy based on an invasive mold infection genetic risk will be double-blinded.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Aspergillosis | — | UNRESOLVED | — |
| Candidiasis | — | UNRESOLVED | — |
| Fungal Infection | — | UNRESOLVED | — |
| Genetic Predisposition | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluconazole | Drug | — | UNRESOLVED |
| Posaconazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- high-risk PTX3 SNPs
- description
- risk predicted by genotyping two PTX3 single nucleotide polymorphisms (SNPs): homozygous for rs230561 and/or rs381652
- interventionNames
- Drug: Posaconazole
- Drug: Fluconazole
- type
- OTHER
- label
- low-risk PTX3 SNPs
- description
- risk predicted by genotyping two PTX3 single nucleotide polymorphisms (SNPs): other than homozygous for rs230561 and/or rs381652
- interventionNames
- Drug: Posaconazole
- Drug: Fluconazole
Primary outcomes (1)
- measure
- Cumulative incidence of proven and probable invasive mold infection (IMI)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available