RecruitingNCT06382922

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

Prospective, Observational Study of the Role of Primary Antifungal Prophylaxis to Prevent Invasive Aspergillosis in Elderly Patients With Acute Myeloid Leukemia Undergoing Consolidation Therapy


Sponsor

University of Rome Tor Vergata

Enrollment

300 participants

Start Date

Mar 29, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 60 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether giving antifungal medication as a preventive measure during consolidation chemotherapy reduces the risk of serious fungal infections in older patients with acute myeloid leukemia (AML). Fungal infections are a serious complication during intensive chemotherapy. **You may be eligible if...** - You are over 60 years old - You have AML and are receiving consolidation chemotherapy (treatment given after achieving remission) with intermediate or high doses of cytarabine - You have signed informed consent **You may NOT be eligible if...** - You developed a serious fungal lung infection (invasive aspergillosis) during your initial (induction) chemotherapy - You are already receiving antifungal treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Tor Vergata University

Roma, RM, Italy

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NCT06382922


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