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
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
The primary endpoint will be the safety defined by the incidence of adverse events occurring during the course of prophylaxis treatment (4 weeks for AL patients and 8 weeks for SCT patients).
Lamine Mahi, MD
Study Director
Gilead Sciences
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
GS-FR-131-104
NCT00362544
October 2003
March 2006
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