First diagnosis of acute lymphoblastic leukaemia in children under one year of age with KMT2A rearrangement or leukaemia with mixed phenotype.
Primary study objective:
The primary objective is to improve outcomes (in terms of event-free survival (EFS) as the primary endpoint) in newly diagnosed KMT2A-rearranged (KMT2A-r) acute lymphoblastic leukaemia (ALL) in children compared to the historical results of the Interfant06 protocol.