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March 14, 2026Therapeutic Advances in HematologyOpen Access

A phase I/II study of gilteritinib in combination with chemotherapy in newly diagnosed patients with AML in Asia: final analysis

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Authors

MSM. SawaAnjo Kosei HospitalTMToshihiro MiyamotoKanazawa UniversityHKHee-Je KimSeoul St. Mary's Hospital

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Implication

Phase I/II study demonstrates safety and efficacy of gilteritinib with chemotherapy in FLT3-mutated AML patients, indicating promising therapeutic options.

Key Points

  • To evaluate the safety and effectiveness of gilteritinib combined with chemotherapy in newly diagnosed, FLT3-mutated acute myeloid leukemia patients.
  • Phase I/II open-label, single-arm study.
  • 84 patients enrolled across 33 centers in Japan, Korea, and Taiwan.
  • Induction treatment with gilteritinib and chemotherapy followed by maintenance with gilteritinib monotherapy.
  • 50.0% complete remission rate after induction.
  • Composite complete remission rate of 86.6% after induction therapy.
  • 71.6% overall survival rate at 3 years, with a median overall survival of 48.2 months.

Cite This Study

Sawa et al. (2026) studied this question.

synapsesocial.com/papers/69b4fc0eb39f7826a300c98dhttps://doi.org/10.1177/20406207261419953
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Also Consider

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  1. 1Gilteritinib as Post-Transplant Maintenance for AML With Internal Tandem Duplication Mutation of FLT32024 · 225 citations
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  3. 3Randomized study of induction therapy comparing standard-dose idarubicin with high-dose daunorubicin in adult patients with previously untreated acute myeloid leukemia: the JALSG AML201 Study2010 · 263 citations
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