drugset / Trial / NCT00362544

PROPHYSOME: Pilot Study on Safety of a Weekly Administration of 10mg/kg of AmBisome® in Antifungal Prophylaxis Treatment of Allogeneic Stem-cell Transplantation and Acute Leukaemia

NCT00362544

Phase 4 Completed 30 enrolled Gilead Sciences
Non-randomizedSingle-groupOpen-labelPrevention

Summary

This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome loading dose regimen, in a weekly administration schedule, during the aplastic phase following induction or consolidation chemotherapy for acute leukaemia, and during the initial phase of allogeneic stem-cell transplant, which are both high risk periods as far as severe fungal infections development is concerned.

Timeline

Start
2003-10
Primary completion
Completion
2006-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Amphotericin B Unknown 10 mg/kg

Indications