Status:
RECRUITING
Study of Posaconazole Prophylaxis in Patients Receiving Hematopoietic Stem Cell Allograft (allo-HSC) At High Risk of Invasive Fungal Infection (IFI)
Lead Sponsor:
Nantes University Hospital
Conditions:
Hematologic Malignancy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 Conferen...
Detailed Description
There are several treatments based on azole molecules: voriconazole, posaconazole, isavuconazole... To date, none of these treatments has been approved for primary post-allograft prophylaxis. Posacona...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Patients with a history of IFI, whether active or resolved at the time of allografting
- 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,
- 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
Key Trial Info
Start Date :
November 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 8 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06541067
Start Date
November 8 2024
End Date
November 8 2028
Last Update
January 30 2025
Active Locations (1)
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1
CHU Nantes
Nantes, France, France, 44000