drugset / Trial / NCT00386997

ProphyALL - Study on the Safety of Liposomal Amphotericin B to Prevent Antifungal Infections in Elderly Patients With Acute Lymphoblastic Leukemia

NCT00386997

Phase 4 Terminated 20 enrolled Gilead Sciences
Non-randomizedSingle-groupOpen-labelPrevention

Summary

Due to the poor outcome of patients with invasive fungal infections (IFI), a more effective prevention of these infections in such patients is wanted. These experiences in intensively treated elderly patients with acute leukemia are especially worrying. This pilot study is designed to collect information on the safety (and efficacy) of an antifungal preventative therapy with an AmBisome® loading dose regimen of 7 mg/kg/week, in four weekly administrations, during the aplastic phase following the start of chemotherapy for acute lymphoblastic leukemia in elderly patients, which is a high risk period for severe fungal infections.

Timeline

Start
2006-11
Primary completion
Completion
2007-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Amphotericin B Unknown 7 mg/kg