Study of posaconazole prophylaxis in patients receiving hematopoietic stem cell allograft (allo-HSC) at high risk of invasive fungal infection (IFI): POSALLO study
- Conditions
- 30 adult patients due to receive an allograft for a myeloid or lymphoid hematological malignancy with an HLA-matched donor from the family or from the international donor file will be included in the hematology departments of the Nantes University Hospital.Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Registration Number
- CTIS2024-511507-42-00
- Lead Sponsor
- Centre Hospitalier Universitaire De Nantes
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Patient = 18 years of age. There is no maximum age for inclusion., Allo-HSC transplant for any type of hematological malignancy or benign disease 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 highly effective contraception during treatment and for 6 months after stopping posaconazole., Hepatitis B, C and HIV serologies negative, Social security affiliation
Patients with a history of IFI, whether active or resolved at the time of allografting, Women or men of childbearing age without effective contraception, Serious, uncontrolled concomitant infections, Yellow fever vaccination within the last year, Patient protected by law (guardianship, curatorship, safeguard of justice), Psychological, family, sociological or geographical conditions that may hinder compliance with the study protocol and follow-up schedule, Patient who does not speak or understand French, Participation in any other therapeutic study with an exclusion period still in effect at the time of inclusion or planned participation in another therapeutic study while taking posaconazole, Patient with known intolerance to posaconazole, Patients with concomitant treatments FORBIDDING association with posaconazole: ergot alkaloids, CYP3A4 substrates (terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine), HMG-CoA reductase inhibitors (simvastatin, lovastatin and atorvastatin) or any other contraindicated treatment listed in VIDAL, patients with congenital or acquired QTc prolongation (QTc >470ms), Cardiac: systolic ejection fraction < 50% by transthoracic ultrasound or isotopic method (isotopic gamma-angiography), Respiratory: DLCOc <40% of theoretical on EFR, Renal: creatinine clearance < 50 ml/min (assessed using MDRD method), Hepatic: transaminases greater than 5 times normal or bilirubin greater than 2 times normal, Pregnant or breast-feeding women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method