Role of Antifungal Prophylaxis in Elderly Patients With Acute Myeloid Leukemia During Consolidation Therapy

Invasive Aspergillosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06382922
• Other study ID #: PAPAML022019
• Status: Recruiting
• Start date: March 29, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: University of Rome Tor Vergata
• Contact: Maria Ilaria Del Principe, Prof
• Phone: 3394080659
• Email: del.principe[@]med.uniroma2.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In previous retrospective study (SEIFEM 2016 study) the investigators evaluated the incidence of proven/probable 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 proven/probable 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 (2.2%) cases of IA [43 probable (1.7%) and 13 proven (0.5%)]. 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 didn't 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 1, 2025
• Est. primary completion date: July 30, 2024
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• Signed written informed consent according to ICH/EU/GCP and national/local laws

• Patients aged older than 60 years underwent to consolidation course with intermediate/high doses of cytarabine

Exclusion Criteria:

• Diagnosis of IA during induction course and previous antifungal treatment

Related Conditions & MeSH terms

• Aspergillosis
• Invasive Aspergillosis
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
Italy	Tor Vergata University	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of proven, probable and possible IA in patients enrolled in the study in both groups of patients	rate of IA	60 months
Secondary	overall mortality rate	rate	60 months