This protocol addresses patients aged 60 years or older with therapy-related acute myeloid leukaemia (tAML) or acute myeloid leukaemia with myelodysplasia-related changes (MRC-AML).
Induction therapy with liposomal daunorubicin and cytarabine (CPX-351) was administered with the goal of achieving complete remission or complete remission with incomplete haematological recovery (CR/CRi), assessed between day 14 and day 21. This protocol defines the consolidation step that follows.
Following induction, eligible patients may receive a limited number of consolidation cycles using a modified version of the induction regimen, with adjustments to both dose and schedule. Further management decisions — including the role of transplantation — depend on remission status and risk classification. The complete treatment algorithm is in the full protocol.