MyeChild-01 is for children with Acute Myeloid Leukemia (AML). It investigates the best dose of chemotherapy and explores if a targeted drug called gemtuzumab ozogamicin can improve survival. The study focuses on finding the right balance of treatment to increase survival rates while reducing the risk of serious side effects.
An international randomised Phase III trial for paediatric Acute Myeloid Leukaemia (AML), incorperating an embedded dose finding study for gemtuzumab ozogamicin in combination with induction chemotherapy. The trial compares two induction chemotherapy regimens: mitoxantrone and cytarabine (current standard treatment) with liposomal daunorubicin and cytarabine. The embedded dose finding study aims to establish the optimum tolerated number of doses of gemtuzumab ozogamicin (up to a maximum of 3 doses) that can be delivered safely in combination with cytarabine plus mitoxantrone or liposomal daunorubicin in induction. The study aims to define the most effective chemotherapy backbone and consolidation strategy for children with newly diagnosed AML.