Allogeneic hematopoietic cell transplantation in acute myeloid leukemia with intermediate-risk - results of the randomized ETAL-1 trial

Abstract The ideal post-remission strategy in patients with intermediate-risk (IR) acute myeloid leukemia (AML) in first complete remission (CR) has been a matter of debate. To address this question, one hundred and forty-three patients with AML, IR cytogenetics in first CR or CRi, aged ≤ 60 years with an available HLA-matched sibling or unrelated donor were randomized 1:1 to either receive allogeneic HCT or high-dose cytarabine for consolidation and salvage HCT only in case of relapse. According to the intent-to-treat analysis, the probability of survival at 2 years was 71% (95%-CI 60-81%) and 84% (95%.CI 73-92%) in Arm A (Primary allogeneic HCT) and Arm B (Chemo-consolidation), respectively (p=.120). Disease-free survival after HCT in CR1 at 2 years was 69% (95%-CI 57-80%) compared to 41% (95%-CI 29-54%; p=.001). The cumulative incidence of relapse was 20% (95% CI 13-31%) and 57% (95%-CI 46-71%; p<.001), respectively. Non-relapse mortality at 2 years after primary allogeneic HCT was below 10% in both arms. No significant differences in health-related quality of life measures were observed. In summary, delayed allogeneic HCT in case of relapse may be a reasonable approach to patients ≤ 60 years of age with intermediate-risk AML in CR1 with an available donor.