ArticleBioanalysis2025
Significant matrix effect in fludarabine quantification in plasma: implications for CAR-T cell therapy monitoring.
Article in Bioanalysis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundEvent-free survival (EFS) in patients with B-cell acute lymphoblastic leukemia (B-ALL) significantly improves with adequate exposure (as Area Under the Curve: AUC RESEARCH DESIGN AND
methodsWe developed and validated an European Medicines Agency (EMA)-compliant high-performance liquid chromatography-tandem mass spectrometry method (HPLC-MS/MS) for FLU TDM, based on similar and published methods, to support clinicians during the patient conditioning phase. All EMA acceptance criteria were met.
resultsAnalysis of real plasma samples revealed unexpectedly high FLU concentrations and, consequently, an excessively high AUC. Analysis of plasma samples from a child receiving FLU therapy highlighted the necessity for accurate drug response verification in real matrices. Preparation of quality controls in FLU-free plasma consistently failed without preliminary dilution. Analysis of internal standard range variation enabled more precise and accurate analyses.
conclusionsThis experience highlights the importance of complementing standard validation tests with analyses in each patient's plasma, collected immediately before FLU infusion, to ensure reliable TDM to support CAR T-cell therapy.
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