Evaluation of MRD Testing in ALL

The standard-of-care for monitoring treatment response in acute lymphoblastic leukemia (ALL) is measurable residual disease (MRD) testing. Several testing methodologies, including immunophenotypic (flow cytometric) and molecular (polymerase chain reaction and next-generation sequencing) assays, are currently utilized. Moreover, optimal treatment time points, sample types and quality, assay protocols, and interpretative strategies are not established. The goal of this guideline is to establish evidence-based standards and expert recommendations in the application, interpretation, and actionability of MRD for pediatric and adult B-cell ALL (B-ALL).

The primary goal of this guideline is to address clinical evaluation of MRD in ALL. The evidence-based recommendations will focus on optimal MRD testing methods.

1a. In patients with Philadelphia chromosome negative (Ph-) B-ALL, which method (flow cytometry or NGS) is best for evaluating MRD status at post-induction, post-consolidation, pretransplant, and posttransplant treatment timepoints?

1b. In patients with Philadelphia chromosome positive (Ph+) B-ALL, which method (PCR, flow cytometry, or NGS) is best for evaluating MRD status at post-induction, post-consolidation, pretransplant, and posttransplant treatment timepoints?

2. In patients with B-ALL, do peripheral blood specimens have concordance with bone marrow aspirates for detecting MRD?

3. For bone marrow aspirates from B-ALL patients, what are the optimum and minimum cellularity requirements for accurate assessment of MRD?

• Guideline status: Research and Review
• Collaborators: Association for Molecular Pathology (AMP) and International Clinical Cytometry Society (ICCS)

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