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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.

Phase 2RecruitingNantes University HospitalNCT06541067Data as of May 2026

Treatment: PosaconazolePatients 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.

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Extracted 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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