Evaluating antifungal prevention in elderly patients with acute myeloid leukemia during chemotherapy
Prospective, Observational Study of the Role of Primary Antifungal Prophylaxis to Prevent Invasive Aspergillosis in Elderly Patients With Acute Myeloid Leukemia Undergoing Consolidation Therapy
This study tests whether giving antifungal medicine to older patients with acute myeloid leukemia during chemotherapy can help prevent serious fungal infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 60 Years to 80 Years |
| Sex | All |
| Sponsor | University of Rome Tor Vergata Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT06382922 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of mold active antifungal prophylaxis in elderly patients over 60 years old who are undergoing consolidation chemotherapy with intermediate or high doses of cytarabine for acute myeloid leukemia. The study builds on previous findings from a multicenter retrospective analysis that identified the incidence of invasive aspergillosis in this patient population. By evaluating the outcomes of patients receiving antifungal prophylaxis, the study seeks to determine its protective role against invasive fungal infections during a critical treatment phase.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged over 60 years who are undergoing consolidation chemotherapy with intermediate or high doses of cytarabine.
Not a fit: Patients who have been diagnosed with invasive aspergillosis during the induction course or those who have received previous antifungal treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of invasive aspergillosis and improve survival rates in elderly patients with acute myeloid leukemia.
How similar studies have performed: Previous studies have indicated varying antifungal policies and outcomes, suggesting that this approach may provide valuable insights, although it is building on existing knowledge rather than being entirely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Roma, RM
- Tor Vergata University — Roma, Rm, Italy (Recruiting)
Study contacts
- Principal investigator: Maria Ilaria Del Principe — University of Rome Tor Vergata
- Study coordinator: Maria Ilaria Del Principe, Prof
- Email: del.principe@med.uniroma2.it
- Phone: 3394080659
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.