Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382922
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-20
Brief Title:
Role of Antifungal Prophylaxis in Elderly Patients With Acute Myeloid Leukemia During Consolidation Therapy
Sponsor:
University of Rome Tor Vergata
Organization:
University of Rome Tor Vergata
Study Overview
Official Title:
Prospective Observational Study of the Role of Primary Antifungal Prophylaxis to Prevent Invasive Aspergillosis in Elderly Patients With Acute Myeloid Leukemia Undergoing Consolidation Therapy
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In previous retrospective study SEIFEM 2016 study the investigators evaluated the incidence of provenprobable invasive aspergillosis IA and the role of mold active primary antifungal prophylaxis PAP in a real life setting of acute myeloid leukemia AML patients receiving intensive consolidation therapy All cases of provenprobable IA observed during consolidation chemotherapy in adult and pediatric AML patients between 2011 and 2015 were retrospectively collected in a multicenter study involving 38 Italian hematologic centers The investigators observed 56 22 cases of IA 43 probable 17 and 13 proven 05 The overall mortality rate and the mortality rate attributable to IA AMR on day 120 were 16 and 9 respectively In multivariate analysis parameters that influenced the outcome were age 60 years and treatment with high doses of cytarabine HDAC
The investigators also observed that centers involved in this survey had different antifungal policies during the AML consolidation phase The results from this study show that in a large real-world setting the mold active PAP with itraconazole or posaconazole decreases the rate of IA after consolidation course
In SEIFEM 2016 study the investigators demonstrated that the incidence of IA during the AML consolidation is low However the mortality is not negligible mainly in older patients Further a sub-analysis in the subset of patients older than 60 years demonstrated that patients who didnt receive mold active prophylaxis had higher incidence of IA than patients who received mold active prophylaxis 15 vs 6 Therefore as prophylaxis seems to prevent IA in consolidation further studies should be performed especially in elderly patients treated with HDAC to confirm our data and to identify the subset of patients who require PAP
The investigators also observed that centers involved in this survey had different antifungal policies during the AML consolidation phase The results from this study show that in a large real-world setting the mold active PAP with itraconazole or posaconazole decreases the rate of IA after consolidation course
In SEIFEM 2016 study the investigators demonstrated that the incidence of IA during the AML consolidation is low However the mortality is not negligible mainly in older patients Further a sub-analysis in the subset of patients older than 60 years demonstrated that patients who didnt receive mold active prophylaxis had higher incidence of IA than patients who received mold active prophylaxis 15 vs 6 Therefore as prophylaxis seems to prevent IA in consolidation further studies should be performed especially in elderly patients treated with HDAC to confirm our data and to identify the subset of patients who require PAP
Detailed Description:
Evaluate the protective role of mold active PAP in patients older than 60 years underwent to chemotherapy of consolidation with intermediate or high doses of cytarabine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None