Gilteritinib for Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia: from Biology to Clinical Practice (Experience of the AF Tsyb Medical Radiological Research Center)

Daniil Arturovich Manaenkov, N.A. Falaleeva, V.A. Shuvaev, A.V. Podenok, A.V. Zherdeva, E.N. Babich,

DOI:

https://doi.org/10.21320/2500-2139-2026-19-4-434-442

Mutations in the FLT3 gene, predominantly of the FLT3-ITD type, are ubiquitous molecular genetic abnormalities associated with unfavorable prognosis in acute myeloid leukemias (AML). In recent years, new FLT3-targeted inhibitors have been actively introduced into clinical practice; their combination with the standard chemotherapy regimens yields the improvement of treatment outcomes in this patient cohort. This paper reports the personal clinical experience and the outcomes of treating three patients with newly diagnosed AML and the FLT3-ITD mutation. All patients received “7+3” induction therapy combined with gilteritinib followed by high-dose cytarabine (HiDAC) and gilteritinib consolidation. Complete remission with incomplete peripheral blood recovery was achieved in all patients. In two patients, MRD negativity and eradication of the FLT3 clone were reported, which allowed to perform allogeneic hematopoietic stem cell transplantation (allo-HSCT), haploidentical and from unrelated donor, respectively. Both patients sustain remission and 100 % donor chimerism. The third patient, despite his deep response, could not receive transplantation due to the lack of an available donor, which resulted in an early disease relapse. In one case, the treatment was complicated by infections and hemophagocytic lymphohistiocytosis, which had been successfully controlled by Janus kinase inhibitor (ruxolitinib). Thus, the integration of gilteritinib into the first-line induction and consolidation regimens can be regarded as an effective strategy for the treatment of AML with FLT3 mutation, as it provides deep (MRD-negative) response. The key factor in the long-term control of the disease is allo-HSCT during the first complete remission.

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  • Daniil Arturovich Manaenkov,  , AF Tsyb Medical Radiological Research Center, branch of the NMRC of Radiology, 4 Koroleva ul., Obninsk, Kaluga Region, Russian Federation, 249036, e-mail: manaenkov.00@inbox.ru

Published

01.10.2026

Issue

MYELOID TUMORS

How to Cite

Manaenkov D.A., Falaleeva N.A., Shuvaev V.A., Podenok A.V., Zherdeva A.V., Babich E.N. Gilteritinib for Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia: from Biology to Clinical Practice (Experience of the AF Tsyb Medical Radiological Research Center). Clinical Oncohematology. Basic Research and Clinical Practice. 2026;19(4):434–442. doi:10.21320/2500-2139-2026-19-4-434-442.

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