Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541067
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Study of Posaconazole Prophylaxis in Patients Receiving Hematopoietic Stem Cell Allograft Allo-HSC at High Risk of Invasive Fungal Infection IFI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study of Posaconazole Prophylaxis in Patients Receiving Hematopoietic Stem Cell Allograft Allo-HSC at High Risk of Invasive Fungal Infection IFI POSALLO Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POSALLO
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 Conference on Infections in Leukemia ECIL6 primary prophylaxis of invasive fungal infections IFI in allograft patients was based on the administration of fluconazole until D100 Due to changes in transplantation practices alternative donor transplantation sequential transplantation etc and changes in microbiological ecology increased incidence of IFIs caused by filamentous germs such as aspergillosis and mycormycosis fluconazole prophylaxis is now sometimes suboptimal It is therefore recommended that patients at high risk of developing IFIs should be given azole molecules with activity against filamentous agents as primary prophylaxis during the first 3 months after transplantation
Posaconazole is often under-dosed below the minimum effective concentration It therefore seems essential to carry out a prospective study with close Cmin dosing in the specific situation of allograft patients a population that appears to be at risk of underdosing in the light of initial retrospective analysis results
Posaconazole is often under-dosed below the minimum effective concentration It therefore seems essential to carry out a prospective study with close Cmin dosing in the specific situation of allograft patients a population that appears to be at risk of underdosing in the light of initial retrospective analysis results
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 Posaconazole is indicated in cases of graft-versus-host disease GVHD requiring systemic corticosteroid therapy after allo-CSH and as primary prophylaxis during aplasia in patients with acute myeloblastic leukemiamyelodysplasia AMLMDS Other azole molecules are not approved for primary prophylaxis and may give rise to drug interactions with certain treatments prescribed for allograft patients eg ciclosporin letermovir
Although recommendations for the administration of posaconazole as primary prophylaxis post allo-CSH have been in place for 4 years few studies are available to date The adult hematology department of Nantes University Hospital conducted a retrospective study of 70 allograft patients at high risk of IFI between 042020 and 122021 Posaconazole treatment was administered from D0 or the day after the 2nd dose of post-transplant cyclophosphamide to D100 Treatment was generally well tolerated with discontinuation due to possible treatment toxicity in 126 of cases mainly of hepatic origin n7 Posaconazole was resumed in 2 cases without recurrence of toxicity In 842 of patients no IFI was observed One of the limitations of this study was the low number of determinations of residual posaconazole concentration Cmin In fact Cmin was carried out in only 59 patients70 with a median delay of 9 days In 43 of cases the Cmin was insufficient 05 mgL which is significantly lower than the Cmin obtained in patients with AMLMDS undergoing induction Cmin 05 mgL 5 of patients It therefore seems essential to carry out a prospective study with close Cmin measurement in the specific situation of allograft patients a population that appears to be at risk of underdosing in the light of the initial retrospective results of analyses
Although recommendations for the administration of posaconazole as primary prophylaxis post allo-CSH have been in place for 4 years few studies are available to date The adult hematology department of Nantes University Hospital conducted a retrospective study of 70 allograft patients at high risk of IFI between 042020 and 122021 Posaconazole treatment was administered from D0 or the day after the 2nd dose of post-transplant cyclophosphamide to D100 Treatment was generally well tolerated with discontinuation due to possible treatment toxicity in 126 of cases mainly of hepatic origin n7 Posaconazole was resumed in 2 cases without recurrence of toxicity In 842 of patients no IFI was observed One of the limitations of this study was the low number of determinations of residual posaconazole concentration Cmin In fact Cmin was carried out in only 59 patients70 with a median delay of 9 days In 43 of cases the Cmin was insufficient 05 mgL which is significantly lower than the Cmin obtained in patients with AMLMDS undergoing induction Cmin 05 mgL 5 of patients It therefore seems essential to carry out a prospective study with close Cmin measurement in the specific situation of allograft patients a population that appears to be at risk of underdosing in the light of the initial retrospective results of analyses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None