The ITCC-101/APAL2020K (NCT06376162) is a phase 1 trial designed to assess the safety and determine the RP2D of ziftomenib in combination with chemotherapy for children with relapsed/refractory KMT2A-r, NUP98-r, or NPM1-m acute leukemias [68], in the context of a pediatric obligation (Pediatric investigation plan, EMA; Pediatric study plan, FDA). This evidence concerns the gene KMT2A and acute leukemia.