Safety and PK of Oral Encochleated Amphotericin B (CAMB/MAT2203) for Antifungal Prophylaxis in Patients Undergoing Induction Chemotherapy for Acute Myelogenous and Lymphoblastic Leukaemia

Inclusion Criteria: * Newly diagnosed AML/ALL receiving chemotherapy inducing neutropenia \< 500 cells/mm3 * Able to have all screening tests done to allow for study drug administration no later than 5 days after start of chemotherapy * Sign informed consent * ≥ 18 years of age Exclusion Criteria: * Known hypersensitivity to amphotericin B, specifically anaphylactic reaction * Fungal induced fever (≥ 38°C) * Proven, possible or probably invasive fungal infection in previous 12 months * Serum galactomannan index (GMI)≥ 0.5 at screening * Pulmonary infiltrates at screening * Current treatment with amphotericin B * Sever comorbidity other than underlying haematological disease * Prolongation of corrected QT interval * History of convulsion * Pregnant or breastfeeding * Females of childbearing potential who do not practice sexual abstinence or who do not agree to use appropriate contraceptive methods * Presence of hepatic disease * Total bilirubin \> 3 x upper limit of normal * Age-adjusted creatinine clearance \< 30 mL/minute * Participating in any other clinical study