Multicenter Flow Cytometry For Acute Myeloid Leukemia Measurable Residual Disease With LAIP/DfN And CD34+CD38-...

Area of Science:

• Hematology
• Clinical Trials
• Immunophenotyping

Background:

• Measurable residual disease (MRD) monitoring is crucial for evaluating treatment response in acute myeloid leukemia (AML) per ELN 2025 guidelines.
• Standardized MRD assessment is needed for reliable clinical trial outcomes.

Purpose of the Study:

• To implement a harmonized MRD flow cytometry approach across 30 French laboratories for AML clinical trials.
• To establish standardized wet-lab procedures and clinical reporting for comparable MRD results.

Main Methods:

• Designed a 3-tube, 8-color flow cytometry panel with common markers for leukemia-associated immunophenotype (LAIP) detection.
• Included protocols for sample preparation, instrument standardization (using rainbow beads), and external quality assessment (wet and dry EQA).
• Adapted flow cytometry settings for multiple platforms and validated with healthy bone marrow samples.

Main Results:

• Developed a feasible multicenter approach for standardized MRD assessment in AML.
• Demonstrated the importance of harmonizing instrument sensitivity, sample preparation, and operator training.
• Established a robust framework for consistent MRD detection across diverse laboratory settings.

Conclusions:

• The harmonized MRD flow cytometry protocol enables reliable and comparable assessment of treatment response in AML clinical trials.
• Successful implementation requires standardization of technical procedures and data analysis strategies.
• This approach supports the accurate evaluation of MRD in AML, aligning with current clinical guidelines.