Current chronic lymphocytic leukemia (CLL) International Prognostic Index (IPI) stratifies patients based on clinical, molecular, and biochemical features; however, B‐cell markers also influence CLL outcomes. Here, prognostic roles of CD11c, CD38, and CD49d were first evaluated, and then an immunophenotypic score was combined with CLL‐IPI for risk stratification of CLL patients.

Implementation of International Prognostic Index with flow cytometry immunophenotyping for better risk stratification of chronic lymphocytic leukemia

Measurable residual disease (MRD) status in chronic lymphocytic leukemia (CLL), assessed on and after treatment, correlates with increased progression-free and overall survival benefit. More recently, MRD assessment has been included in large clinical trials as a primary outcome and is increasingly used in routine practice as a prognostic tool, a therapeutic goal, and potentially a trigger for early intervention. Modern therapy for CLL delivers prolonged remissions, causing readout of traditional trial outcomes such as progression-free and overall survival to be inherently delayed. This represents a barrier for the rapid incorporation of novel drugs to the overall therapeutic armamentarium. MRD offers a dynamic and robust platform for the assessment of treatment efficacy in CLL, complementing traditional outcome measures and accelerating access to novel drugs. Here, we provide a comprehensive review of recent major clinical trials of CLL therapy, focusing on small-molecule inhibitors and monoclonal antibody combinations that have recently emerged as the standard frontline and relapse treatment options. We explore the assessment and reporting of MRD (including novel techniques) and the challenges of standardization and provide a comprehensive review of the relevance and adequacy of MRD as a clinical trial endpoint. We further discuss the impact that MRD data have on clinical decision-making and how it can influence a patient’s experience. Finally, we evaluate how upcoming trial design and clinical practice are evolving in the face of MRD-driven outcomes.

/pdf/the-evolving-use-of-measurable-residual-disease-in-chronic-1iqb23vw.pdf

The evolving use of measurable residual disease in chronic lymphocytic leukemia clinical trials

The diagnosis of leukemic B-cell lymphoproliferative disorders (B-LPDs) is made by integrating clinical, cytological, cytometric, cytogenetic, and molecular data. This leaves room for differences and inconsistencies between experts. In this study, we examine methodological and conceptual aspects of the flow cytometric classification of leukemic B-LPDs that could explain them. Among methodological aspects, we discuss (1) the different statistical tests used to select and evaluate markers, (2) how these markers are analyzed, (3) how scores are interpreted, (4) different degrees to which diagnostic information is used, and (5) and the impact of differences in study populations. Among conceptual aspects, we discuss (1) challenges to integrating different biological data points, (2) the under examination of the costs of misclassification (false positives and false negatives), and finally, (3) we delve into the impact of the lack of a true diagnostic gold standard and the indirect evidence suggesting poor reproducibility in the diagnosis of leukemic B-LPDs. We then outline current harmonization efforts and our personal approach. We conclude that numerous flow cytometry scores and diagnostic systems are now available; however, as long as the considerations discussed remain unaddressed, external reproducibility and interobserver agreement will not be achieved, and the field will not be able to move forward if a true gold standard is not found. 

Methodological and conceptual challenges to the flow cytometric classification of leukemic lymphoproliferative disorders

Current Landscape of Ancillary Diagnostic Testing in Chronic Lymphocytic Leukemia.

The 10-color panel consisting of 21 monoclonal antibodies (mAbs) is developed as a one-tube panel to detect leukemia and lymphoma cells in all hematopoietic cell lineages. In particular, this tube is mentioned for a fast screening to identify aberrant cells in samples suspected for malignant cell localization and to enable comprehensive immunophenotyping of samples with low cell counts. The panel contains mAbs for selection of the populations and mAbs against target antigens on the various hematopoietic maturation stages. Due to the limited number of PMTs in most used flow cytometers for clinical purposes, stacking of conjugates in one color is needed to include all relevant markers for simultaneous analysis of the aberrant cells. The 21-mAb panel is tested on peripheral blood (PB), and bone marrow (BM) samples and enables an efficient and correct identification of hematological malignancies. This panel improves the diagnostic potential.

OMIP - 081: A new 21-monoclonal antibody 10-color panel for diagnostic polychromatic immunophenotyping

Diagnosis and minimal residual disease (MRD) monitoring of chronic lymphocytic leukemia (CLL) by flow cytometry currently requires multiple antibody panels. We added CD23 and CD200 to the EuroFlowT...

A 10-color flow cytometry panel for diagnosis and minimal residual disease in chronic lymphocytic leukemia.

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A 10-color flow cytometry panel for diagnosis and minimal residual disease in chronic lymphocytic leukemia.