To examine the prognostic significance of minimal residual disease (MRD) in t(8;21) acute myeloid leukemia (AML), 96 bone marrow samples from 26 Japanese patients in complete remission (CR) were analyzed regarding the RUNX1/MTG8 transcript using real-time reverse transcriptase polymerase chain reaction assay. All patients were treated with intensive chemotherapy. The median copy number of the RUNX1/MTG8 transcript, measured after each treatment course decreased over time. However, an increase in the MRD level was documented in three patients after the second consolidation, and all of them subsequently relapsed. The relapse-free survival (RFS) did not differ between the patients whose MRD levels were below or above 1,000 copies/microg after the first consolidation, with respective 2-year rates of 62 and 86% (P = 0.21). With respect to the MRD level after induction therapy, our data also failed to show any favorable effect of a lower MRD on RFS. Although these findings need to be confirmed with a larger number of patients, our data indicate that the MRD level at a given time during the early course in CR does not predict the outcome in Japanese patients.