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ALL-5: Exploring the prognostic significance of minimal residual disease (MRD) in children with ALL

ALL, HARMONY, Leukemia


Quantification of minimal residual disease (MRD) is a cornerstone of treatment response assessment and risk stratification in acute lymphoblastic leukemia (ALL), and the prognostic impact of MRD at different time points has been investigated across many therapeutic protocols. However, at present, there remains a lack of established prognostic biomarkers for risk stratification, especially in T-ALL,  which reflect the underlying disease burden. Additionally, apart from absolute MRD values, the combined evaluation of MRD, and the analysis of log reduction rates between different time points, reflecting the different blast clearance kinetics and possibly different underlying biology, is still an issue that has not been addressed and fully evaluated. In this frame, there are few data on evaluated blast clearance kinetics between the time-points of day 15 and end of induction (EOI) therapy, as well between the time points of end of induction (EOI) and end of consolidation (EOC).  

Previous results suggest that MRD quantifications, log-reduction rates and blast clearance kinetics impact survival and relapse outcomes significantly. This study aims to determine whether the combination of MRD values, and evaluation of the leukemia burden decrease by log-reduction rates, may provide a new tool for predicting relapse and patient outcomes in both B-cell and T-cell ALL.

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Project Summary

There has been no evaluation of the combination of MRD, log-reduction rates between different time points, the different blast clearance kinetics and possible underlying copy number aberrations (CNAs). Therefore, this research aims to describe the prognostic significance of MRD log reduction in pediatric ALL patients at different time points during induction and consolidation therapy using data from the HARMONY database.

This retrospective analysis will utilize data from both B-cell and T-cell ALL pediatric patients which has been obtained by flow cytometry (FC) or polymerase chain reaction (PCR) measurement of MRD. MRD data from approximately 1000 ALL patients will be analyzed, with a sole focus on patients <18 years old. Data will be analyzed using numerous approaches, including the evaluation of key survival endpoints and specific patient subgroups. 

The overall aims of this study are as follows: