NCT03828773Recrutement en cours
PTX3-targeted Antifungal Prophylaxis
Résumé
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.
Critères d'inclusion
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).
Critères d'exclusion
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)
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Sans phase (N/A)
- Type d'étude
- Interventionnelle
- Pays
- Suisse, France, Belgique
- Promoteur
- Bochud Pierre-Yves(Autre)
- N° de protocole
- 2018-01671
- Pathologies
- Candidiasis, Fungal Infection, Acute Myeloid Leukemia, Genetic Predisposition, Aspergillosis
- Interventions
- Médicament
Traitements évalués
- Posaconazole
- Fluconazole
Collaborateurs
Swiss National Science Foundation
Lieux · 8
- Aarau, SuisseCantonal Hospital AarauRecrute dans ce centre
- Basel, SuisseUniversity Hospital BaselRecrute dans ce centre
- Fribourg, SuisseCantonal Hospital HFRRecrute dans ce centre
- Geneva, SuisseUniversity Hospital of Geneva (HUG)Recrute dans ce centre
- Lausanne, SuisseUniversity Hospital of Lausanne / Centre Hospitalier Universitaire Vaudois (CHUV)Recrute dans ce centre
- Créteil, FranceHenri Mondor HospitalRecrute dans ce centre
- Bruges, BelgiqueAZ Sint-Jan HospitalRecrute dans ce centre
- Leuven, BelgiqueUniversity Hospital Leuven (UZ Leuven)Recrute dans ce centre
Au total, dans le monde, 8 des 9 centres listés au registre recrutent ; l'autre ne recrute pas actuellement.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 9 décembre 2025).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
Autres identifiants
- 2018 · financement NIH
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.