2018-01671 (PTX targeted prophylaxis)

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

Study treatments

Risk predicted by genotyping two PTX3 single nucleotide polymorphisms (SNPs): homozygous for rs230561 and/or rs381652  - treatment with posaconazole or fluconazole

Inclusion criteria

• Age ≥18 years.
• Diagnosis of Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome in transformation (MDSit) treated with an intensive chemotherapy regimen, including induction / consolidation / salvage remission chemotherapy.
• Planned hospital admission for the duration of the neutropenic phase (absolute neutrophils count <500 cells/mm3).

Exclusion criteria

• Patients with neutropenia (absolute neutrophils count<500 cells/mm3) upon presentation and prior to chemotherapy initiation.
• Patients with a diagnosis of acute promyelocytic leukemia (APL) or AML-M3.
• Patients with known history of allergy, hypersensitivity or serious reaction to azole antifungals
• 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.

Participating sites

• University Hospital Leuven Gasthuisberg