Using Posaconazole to Prevent Fungal Infections in High-Risk Stem Cell Transplant Patients
Study of Posaconazole Prophylaxis in Patients Receiving Hematopoietic Stem Cell Allograft (Allo-HSC) at High Risk of Invasive Fungal Infection (IFI): POSALLO Study
This study is testing if Posaconazole can help prevent serious fungal infections in patients who are at high risk after receiving a stem cell transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Drugs / interventions | cyclophosphamide |
| Locations | 1 site (Nantes, France) |
| Trial ID | NCT06541067 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of Posaconazole as a primary prophylactic treatment for patients receiving an allogeneic hematopoietic stem cell transplant (allo-CSH) who are at high risk for invasive fungal infections (IFI). The study aims to address the limitations of traditional fluconazole prophylaxis, which may be inadequate due to changes in transplantation practices and increased incidence of certain fungal infections. Participants will receive Posaconazole starting from the day of transplantation and continuing for three months, with monitoring for efficacy and safety. The trial seeks to establish the optimal dosing and effectiveness of Posaconazole in preventing IFIs in this vulnerable patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are undergoing allo-CSH for hematologic malignancies and meet specific high-risk criteria for fungal infections.
Not a fit: Patients who do not meet the eligibility criteria, such as those with a history of certain infections or those not undergoing allo-CSH, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of invasive fungal infections in high-risk stem cell transplant patients, improving their overall survival and quality of life.
How similar studies have performed: While there have been few studies on Posaconazole for this specific use, existing research indicates promising results in preventing fungal infections in similar high-risk populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Nantes, France
- CHU Nantes — Nantes, France, France (Recruiting)
Study contacts
- Study coordinator: Amandine LE BOURGEOIS, MD
- Email: amandine.lebourgeois@chu-nantes.fr
- Phone: 02 40 08 32 71
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.