OncoMatch/Clinical Trials/NCT06541067
Study of Posaconazole Prophylaxis in Patients Receiving Hematopoietic Stem Cell Allograft (Allo-HSC) at High Risk of Invasive Fungal Infection (IFI)
Is NCT06541067 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Posaconazole for hematologic malignancy.
Treatment: Posaconazole — Patients receiving an allogeneic hematopoietic stem cell transplant (allo-CSH) are at high risk of infection, particularly of fungal origin. Until the 2018 recommendations of the 6th European Conference on Infections in Leukemia (ECIL6), primary prophylaxis of invasive fungal infections (IFI), in allograft patients, was based on the administration of fluconazole until D100. Due to changes in transplantation practices (alternative donor transplantation, sequential transplantation, etc.) and changes in microbiological ecology (increased incidence of IFIs caused by filamentous germs such as aspergillosis and mycormycosis), fluconazole prophylaxis is now sometimes suboptimal. It is therefore recommended that patients at high risk of developing IFIs should be given azole molecules with activity against filamentous agents as primary prophylaxis during the first 3 months after transplantation. Posaconazole is often under-dosed (below the minimum effective concentration). It therefore seems essential to carry out a prospective study with close \[C\]min dosing in the specific situation of allograft patients, a population that appears to be at risk of underdosing in the light of initial retrospective analysis results.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Kidney function
creatinine clearance < 50 ml/min (assessed using MDRD method) [excluded]
Liver function
transaminases greater than 5 times normal or bilirubin greater than 2 times normal [excluded]
Cardiac function
systolic ejection fraction < 50% by transthoracic ultrasound or isotopic method (isotopic gamma-angiography) [excluded]
Cardiac: systolic ejection fraction < 50% by transthoracic ultrasound or isotopic method (isotopic gamma-angiography); Renal: creatinine clearance < 50 ml/min (assessed using MDRD method); Hepatic: transaminases greater than 5 times normal or bilirubin greater than 2 times normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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