Study of posaconazole prophylaxis in patients receiving hematopoietic stem cell allograft (allo-HSC) at high risk of invasive fungal infection (IFI): POSALLO study

Centre Hospitalier Universitaire De Nantes0 个研究点目标入组 30 人开始时间: 2024年6月4日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•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

发起方

Centre Hospitalier Universitaire De Nantes