Prophylaxis of Fungal Invasive Infections in Leukemia

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

• To assess the overall clinical yield - in terms of efficacy and safety endpoints of adding caspofungin as prophylaxis of Invasive Pulmonary Aspergillosis in patients undergoing induction treatment for newly diagnosed acute leukemia

• To investigate the prognostic significance of Ptx3 at diagnosis and during the first chemotherapy cycle with respect to the development of IPA

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northern Italy Leukemia Group
• Treatments: Caspofungin; Echinocandins

Criteria

Inclusion Criteria:

• all patients with a diagnosis af acute leukemia who are enrolled in the clinical protocols of NILG for acute leukemia at diagnosis

• age > 18

• written informed consent

Exclusion Criteria:

• presence of signs or symptoms suspected of invasive fungal infection at enrollment

• history of allergy, hypersensitivity, or any serious reaction to echinocandin

• pregnancy or breast-feeding

• acute hepatitis or moderate/severe hepatic insufficiency of any cause;

• concomitant treatment with any systemic antifungal agent

• recent prior use of caspofungin