Individualized therapy of patients with leukemia based on WT1 assay.

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We have reported that a high expression of WT1 gene is observed in almost all patients with leukemia, and that the detection of minimal residual disease (MRD) can be done in a sensitivity of 10^<-3> to 10^<-5> by the quantitation of WT1 gene expression levels on real-time PCR method. A low level of WT1 gene expression which is observed in CD34+ cells have been found to result in the background level expression of WT1 in bone marrow specimens. In this present study, the background levels of WT1 gene expression was found to reduce in one order in patients after bone marrow transplantation (BMT), by analyzing the WT1 gene expression in bone marrow samples in. which chimeric gene expressions could not be detected in RT-PCR analysis. These findings indicate that the sensitivity to detect MRD was increased after BMT.Furthermore, in the analysis of WT1 levels in patients who underwent BMT, a low level of WT1 gene expression before BMT, the HLA disparity between donors and recipients, and the presence of clinical graft-versus-host disease were found to be good prognostic factors to obtain a continuous complete remission.