A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of Prophylactic Liposomal Amphotericin B (AmBisome®) for the Prevention of Invasive Fungal Infections (IFIs) in Subjects Receiving Remission-Induction Chemotherapy for Acute Lymphoblastic Leukemia (ALL)
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
proportion of subjects with proven or probable invasive fungal infections
Proportion of subjects diagnosed with proven or probable IFIs during remission induction chemotherapy for ALL. Diagnoses of proven or probable IFIs will be assessed according to EORTC/MSG criteria by an independent data review board (IDRB) who will be blinded to subject treatment assignment.
during remission induction chemotherapy for ALL (up to 12 weeks)
Mike Hawkins, MD
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica