Study of Posaconazole Prophylaxis in Patients Receiving Hematopoietic Stem Cell Allograft (allo-HSC) At High Risk of Invasive Fungal Infection (IFI): POSALLO Study
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.
• Patient ≥ 18 years of age. There is no maximum age for inclusion
• Allo-CSH transplant for hematologic malignancy or benign hemopathy of any type with one or more high risk IFI criteria:
‣ alternative donor (haploidentical intra-family donor, mismatch file donor, placental blood)
⁃ sequential conditioning for disease not in remission at the time of transplantation
⁃ use of post-transplant cyclophosphamide (PTCY) for GVH prophylaxis
⁃ patient who has previously received a HSC allograft
• Written informed consent prior to protocol initiation
• ECOG \<=2
• Female of childbearing age with negative pregnancy test and on highly effective contraception during treatment and for 12 months after posaconazole discontinuation
• Men of childbearing age with effective contraception during treatment and for 6 months after stopping posaconazole.
• Hepatitis B, C and HIV serologies negative.
• Social security affiliation