CTIS2024-511507-42-00
Active, not recruiting
Phase 1
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 sites30 target enrollmentStarted: June 4, 2024Last updated:
Conditions30 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]
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Centre Hospitalier Universitaire De Nantes
- Enrollment
- 30
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
Similar Trials
Active, not recruiting
Not Applicable
Investigation of posaconazole prophylaxis in children with chronic granulomatous disease (CGD): pharmacokinetics and tolerability (iPOD) - iPODChildren with chronic granulomatous disease (CGD).MedDRA version: 9.1Level: LLTClassification code 10008906Term: Chronic granulomatous diseaseEUCTR2008-004518-28-NLRadboud University Nijmegen Medical Centre
Completed
Phase 2
Investigation of posaconazole prophylaxis in children with chronic granulomatous disease (CGD): pharmacokinetics and tolerability (iPOD).NL-OMON32626niversitair Medisch Centrum Sint Radboud20
Active, not recruiting
Not Applicable
Investigation of posaconazole prophylaxis in children with chronic granulomatous disease (CGD): pharmacokinetics and tolerability (iPOD) - iPODEUCTR2008-004518-28-GBRadboud University Nijmegen Medical Centre20
Recruiting
Not Applicable
Posaconazole fungal keratitisHealth Condition 1: H160- Corneal ulcerCTRI/2021/05/033591V Prasad Eye Institute
Completed
Phase 4
A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface AreaHematological MalignancyNCT02372357Universitaire Ziekenhuizen KU Leuven14