Biopolym. Cell. 2026; 42(Special Issue):79.
Biomarkers and molecular diagnostics
A novel CD7×FLT3-ITD risk stratification model for predicting post-transplant outcomes in acute myeloid leukemia
- Educational and Scientific Center "Institute of Biology and Medicine",
Taras Shevchenko National University of Kyiv
64/13, Volodymyrska Str., Kyiv, Ukraine, 01601 - Municipal Non-Commercial Enterprise “Kyiv City Medical Center�
26, Chornykh Zaporozhtsiv Str., Kyiv, Ukraine, 02125
Abstract
Background/Aim. Acute myeloid leukemia (AML) is a heterogeneous malignancy with high relapse risk after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Although molecular and immunophenotypic biomarkers are widely used for risk assessment, their individual prognostic value is limited. This study evaluated integrated leukemiaassociated immunophenotype (LAIP) and molecular profiling, focusing on the CD7 expression and FLT3-ITD status. Methods. This study included 17 adults with AML who underwent allo-HSCT. The bone marrow samples were analyzed by multiparameter flow cytometry and molecular methods (allele-specific PCR and/or next-generation sequencing) for FLT3-ITD/TKD, NPM1, DNMT3A, WT1, RUNX1, IDH1/2, TET2, SF3B1, and other mutations. Clinical outcomes, measurable residual disease (MRD), molecular response, relapse, and survival were assessed. A four-tier risk model was developed: Score 0 (CD7−/FLT3−), Score 1 (CD7−/FLT3+), Score 2 (CD7+/FLT3−), and Score 3 (CD7+/ FLT3+). Results. The most frequent abnormalities were DNMT3A (41.2%), FLT3-ITD (29.4%), RUNX1 (29.4%), and NPM1 (23.5%). Patients with primitive-myeloid-aberrant LAIP showed the greatest molecular complexity and poorest outcomes. The persistence of FLT3-ITD, NPM1, or DNMT3A after transplantation was associated with relapse and death, whereas the complete molecular clearance correlated with sustained remission. The CD7×FLT3-ITD model showed a clear overall risk gradient: no adverse outcomes occurred in Score 0 (0/4) or Score 1 (0/2), compared with 38% (3/8) in Score 2 and 100% (3/3) in Score 3. FLT3-ITD alone did not predict poor outcome in CD7-negative patients, whereas the CD7+/FLT3-ITD+ phenotype identified a uniformly unfavorable clinical subgroup. Among CD7-positive patients, a higher mutational burden, persistence of molecular markers, lack of complete molecular response by 60 days after allo-HSCT, and emergence of de novo mutations were associated with relapse and death. Conclusions. Integration of LAIP and molecular profiling improves post-transplant risk assessment in AML. We propose a novel CD7×FLT3-ITD four-tier stratification model showing that CD7 modifies FLT3-ITD prognostic impact. The CD7+/FLT3-ITD+ phenotype defines a very-high-risk subgroup characterized by persistent molecular disease, clonal evolution, and poor outcome. These findings support combined immunophenotypic and molecular monitoring for personalized post-transplant surveillance and validation in larger prospective cohorts.
Keywords: acute myeloid leukemia, allogeneic hematopoietic stem cell transplantation, CD7, FLT3-ITD, measurable residual disease, risk stratification
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