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

NCT06382922 | Recruiting

• 1 other identifier: PAPAML022019
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Invasive Aspergillosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• overall mortality rate

  60 months

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Considering our previous results and that in the subset of patients older than 60 years patients, who didn't receive mold active prophylaxis had higher incidence of IA than patients who received mold active prophylaxis (15% vs 6%), we calculated that sample side should be 300 patients for arms. This sample size achieves 90% power to detect a difference of 10% .

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of IA during induction course and previous antifungal treatment

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

Tor Vergata University

Roma, RM, 00133, Italy

RECRUITING

Study Officials

• Maria Ilaria Del Principe

  University of Rome Tor Vergata

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Ilaria Del Principe, Prof

CONTACT

3394080659; del.principe@med.uniroma2.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 20, 2024
• First Posted: April 24, 2024
• Study Start: March 29, 2023
• Primary Completion: July 30, 2024
• Study Completion: June 1, 2025
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

IT (1)