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December 8, 2025Blood

Phase I/II study of decitabine/cedazuridine (ASXT727), venetoclax, and gilteritinib for patients with FLT3-mutated Acute Myeloid Leukemia or high-risk myelodysplastic syndrome

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Authors

RARoberta Santos AzevedoNSNicholas J. ShortEJElias Jabbour

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Overview

Phase I/II trial found promising response rate in flt3-mutated AML and MDS with decitabine and venetoclax, indicating feasibility despite myelosuppression.

Key Points

  • To evaluate the safety and efficacy of oral ASTX727, venetoclax, and gilteritinib in FLT3-mutated AML and high-risk MDS.
  • Phase I/II study design targeting FLT3-mutated AML and high-risk MDS patients.
  • Dose-escalation in Phase I and dose-expansion in Phase II with two cohorts.
  • Patients received decitabine, venetoclax, and gilteritinib over specified cycles.
  • Current results show a 71% overall response rate in relapsed/refractory patients.
  • 80% complete remission rate in newly diagnosed patients, with significant minimal residual disease negativity.
  • Notable safety concerns include myelosuppression, requiring dose adjustments.

Cite This Study

Azevedo et al. (2025) studied this question.

synapsesocial.com/papers/69362f764fa91c937236e397https://doi.org/10.1182/blood-2025-997
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Also Consider

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

  1. 1Hypomethylating agents or chemotherapy in combination with venetoclax and gilteritinib for FLT3-mutated Acute Myeloid Leukemia2025 · 1 citations
  2. 2Efficacy of the triplet therapy with venetoclax, azacitidine and gilteritinib for the treatment of FLT3-ITD mutated AML patients with refractory/relapsed disease or persistent minimal residual disease bridging to allogeneic hematopoietic stem cell transplantation2025 · 2 citations
  3. 3Venetoclax (VEN) and azacitidine (AZA) with gilteritinib (GILT) in patients with newly diagnosed (ND) FLT3mut+ Acute Myeloid Leukemia (AML) ineligible for intensive induction chemotherapy (chemo): Interim results from the phase 1/2 VICEROY study2025 · 10 citations
  4. 4Long-Term Outcomes of Azacitidine, Venetoclax and Gilteritinib in Newly Diagnosed FLT3-Mutated AML2026 · 1 citations
  5. 5A 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 study2025