PURPOSE: To evaluate the survival benefit of chemotherapy intensification in older patients with AML who have not achieved a measurable residual disease (MRD)-negative remission. METHODS: Five hundred twenty-three patients with AML (median age, 67 years
range, 51-79) without a flow cytometric MRD-negative remission response after a first course of daunorubicin and AraC (DA
including 165 not in remission) were randomly assigned between up to two further courses of DA or intensified chemotherapy-either fludarabine, cytarabine, granulocyte colony-stimulating factor and idarubicin (FLAG-Ida) or DA with cladribine (DAC). RESULTS: Overall survival (OS) was not improved in the intensification arms (DAC CONCLUSION: In this study of older patients with AML considered fit and with evidence of residual disease after first induction, chemotherapy intensification improved survival. DAC intensification was better tolerated than FLAG-Ida.