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

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.

Details

Lead sponsor	Gilead Sciences
Phase	Phase 4
Status	COMPLETED
Enrolment	30
Start date	2003-10
Completion	2006-03

Conditions

• Leukemia

Interventions

• Ambisome

Primary outcomes

• 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).

Countries

France