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December 8, 2025Blood

A Phase 2 study of sequential administration of gilteritinib after MEC chemotherapy in Relapsed/Refractory FLT3-mutated Acute Myeloid Leukemia in adults: Japan adult leukemia study group (JALSG) RR-FLT3-AML220 study

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Authors

YIYuichi IshikawaTYTakahiro YamauchiTTTomomi Toubai

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Overview

Phase 2 trial shows high complete remission rates in relapsed or refractory FLT3-mutated AML, suggesting gilteritinib may enhance treatment outcomes.

Key Points

  • This study aimed to evaluate the efficacy of sequential gilteritinib administration after MEC chemotherapy in patients with relapsed/refractory FLT3-mutated AML.
  • Phase 2, single-arm study
  • Involved 42 patients with FLT3-mutated R/R AML
  • Sequential administration of MEC chemotherapy followed by gilteritinib for up to 13 cycles
  • Evaluated primary endpoint of complete remission (CR) rate and various secondary endpoints.
  • Included comprehensive genetic analysis and monitoring of adverse events.
  • Achieved CR rate of 48.8% among 41 evaluable patients
  • CRc rate was 87.8%, indicating significant response
  • Median overall survival was 32.2 months
  • Adverse events occurred in 97.6% of patients, with common issues including anemia, neutropenia, and thrombocytopenia.

Cite This Study

Ishikawa et al. (2025) studied this question.

synapsesocial.com/papers/69362f764fa91c937236e398https://doi.org/10.1182/blood-2025-998
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1A phase I/II study of gilteritinib in combination with chemotherapy in newly diagnosed patients with AML in Asia: final analysis2026
  2. 2Real-world effectiveness of gilteritinib beyond second-line therapy in relapsed/refractory FLT3-mutated acute myeloid leukemia: A european multicenter study of 171 patients2025 · 1 citations
  3. 3Treatment sequence with gilteritinib and allogeneic haematopoietic stem cell transplantation in relapsed/refractory FMS‐like tyrosine kinase 3 ( <scp>FLT3</scp> )‐mutated acute myeloid leukaemia patients: A multicentre real‐world study2026
  4. 4Maintenance treatment with gilteritinib suppresses post-transplant relapse in relapse/refractory FLT3-mutated acute myeloid leukemia2026 · 3 citations
  5. 5Maintenance treatment with gilteritinib suppresses post-transplant relapse in relapsed/refractory FLT3-mutated acute myeloid leukemia: A Japanese nationwide registry study2025