Conditions: Invasive Fungal Disease
Keywords: Ambisome ALL invasive fungal infection prophylaxis liposomal amphotericin B Invasive fungal infection prophylaxis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 355
Healthy volunteers: no

Brief summary:
The study aims to investigate whether prophylaxis with liposomal amphotericin B (AmBisome®) can reduce the incidence of invasive fungal infections (IFIs) in patients with Acute Lymphoblastic Leukemia (ALL) who are undergoing their first remission induction.

Detailed description:

Arms:
arm 1: Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy arm 2: Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy

Interventions: intervention 1: Liposomal amphotericin B intervention 2: Placebo
Intervention descriptions: intervention 1: Ambisome 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week during induction chemotherapy intervention 2: Placebo to match liposomal amphotericin B administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy

Protocol document: