PTX3-targeted Antifungal Prophylaxis

Launched by BOCHUD PIERRE-YVES · Feb 1, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness of an antifungal medication called posaconazole for patients with acute myeloid leukemia (AML) who are undergoing intensive chemotherapy. The goal is to see if using this medication can help prevent serious fungal infections, which can be a risk for these patients, especially during the early phase of treatment when their immune systems are weak. Participants will be randomly assigned to receive either the antifungal or a placebo (a harmless substitute), and neither the participants nor the researchers will know who is receiving what until the study is complete.

To be eligible for this study, participants must be at least 18 years old, diagnosed with AML or a related condition, and scheduled for chemotherapy that will lower their white blood cell count for a time. They should also be prepared to stay in the hospital during this vulnerable period. However, individuals with certain conditions, such as severe allergies to antifungal medications or specific heart issues, cannot participate. If you or a family member is considering joining this study, you can expect close monitoring and care from medical professionals throughout the process. Your involvement could help improve treatment options for others facing similar health challenges in the future.

Gender

ALL

Eligibility criteria

• 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).