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Importance  By demonstrating with   TEL ‐ AML 1 , this study indicated that  mRNA s transcribed from fusion genes are ideal targets for minimal residual disease ( MRD ) monitoring in childhood acute lymphoblastic leukemia, and that different thresholds are needed to apply them into the risk stratification.    Objective    TEL ‐ AML 1  expression was measured at three time points to 1) determine cut‐off values for predicting acute lymphoblastic leukemia ( ALL ) relapse; 2) investigate the prognostic value of this method and how well the results at these time points correlated; 3) determine the correlation between  MRD  levels assessed using this marker and that determined by immunoglobulin/T‐cell receptor (Ig/ TCR ) rearrangement detection.    Methods    TEL ‐  AML 1  expression in 62 children with  ALL  was quantitated by real‐time quantitative  PCR  at day 15, day 33, and month 3. The relationship between patient outcome and   TEL ‐ AML 1  level was analyzed at each time point. The correlation between the  MRD  levels determined by   TEL ‐ AML 1  or Ig/ TCR  rearrangements was also analyzed.    Results  For day 33, 6.68   TEL ‐ AML 1  copies/10 4    ABL   copies was determined to be the best cut‐off value. Higher levels were correlated with relapse ( P =  0.001). For day 15 and month 3, the best cut‐off values were 336.5 and 0.85 copies/10 4    ABL   copies respectively; patients with higher expression levels had lower  RFS s (day 15:  P =  0.027; month 3:  P =  0.023). For days 15 and 33,  MRD  levels assessed using   TEL ‐ AML 1  or Ig/ TCR  rearrangements were strongly correlated [Spearman rank correlation coefficient ( ρ ) = 0.729 (day 15), 0.719 (day 33);  P <  0.001 (both)], and both methods were equally effective at predicting relapse. At month 3, there was moderate correlation between the results derived from the two markers ( ρ  = 0.418,  P =  0.003); however, receiver operating characteristic curve analysis showed that   TEL ‐ AML 1  was a better prognostic marker.    Interpretation    TEL ‐ AML 1  is an effective marker for  MRD  assessment and relapse prediction in children with  ALL .

Quantitative monitoring of minimal residual disease in childhood acute lymphoblastic leukemia using TEL ‐ AML 1 fusion transcript as a marker