PTX3-targeted Antifungal Prophylaxis

Korábbi kezelés

• Women who are pregnant (positive blood/urine pregnancy test within 10 days before randomization) or breast-feeding.
• 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.
• Serious uncontrolled concomitant disease or comorbidity that, in the opinion of the investigator, may compromise adherence to the study protocol.
• Receipt of a prior allogeneic Hematopoietic Cell Transplantation (HCT).
• Previous exposure to mold-active prophylaxis (>48 hours within 7 days of inclusion).

Más betegség

• Patients with known history of allergy, hypersensitivity or serious reaction to azole antifungals

Laborértékek

• Patients with neutropenia (absolute neutrophils count<500 cells/mm3) upon presentation and prior to chemotherapy initiation.
• 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.
• Patients with an ECG with a prolonged QTc interval: QTc greater than 450 msec for men and greater than 470 msec for women.
• 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).

Egyéb

• Patients with a diagnosis of acute promyelocytic leukemia (APL) or AML-M3.
• Patients with relapsed leukemia already included in the trial.
• Patient not affiliated to the French social security system
• Patient under legal protection (guardianship, curatorship)

• Signed Informed Consent according to national/local regulations.
• 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).