Synapse
⌘+K
Synapse
PulseExploreClubsResearchersJournals
Instagram
HomeClubsExplore
December 8, 2025BloodOpen Access

Venetoclax (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 study

View Full Paper
Ask AI
Bookmark
Share

Authors

APAlexander E. PerlYDYehuda E. DeutschMBMaria R. Baer

Discussion

Loading...

Member takes

Overview

Interim results show promising efficacy of triplet therapy in patients with newly diagnosed FLT3mut+ acute myeloid leukemia ineligible for intensive chemo.

Key Points

  • Evaluate the efficacy, safety, and optimal dosing of venetoclax, azacitidine, and gilteritinib in patients with newly diagnosed FLT3mut+ acute myeloid leukemia ineligible for intensive induction chemotherapy.
  • Phase 1/2 open-label study with randomization to two venetoclax doses (200mg or 400mg).
  • All patients received azacitidine and gilteritinib in 28-day cycles.
  • Bone marrow testing was performed to assess the impact on blasts and subsequent treatment adjustment.
  • Complete remission rate was 70% for VEN200 and 65% for VEN400.
  • 12-month overall survival rate was 64% for VEN200 and 77% for VEN400.
  • Safety events reported included febrile neutropenia and increased liver enzymes, with a main focus on dose-limiting toxicities.

Cite This Study

Perl et al. (2025) studied this question.

synapsesocial.com/papers/69362f3a4fa91c937236d447https://doi.org/10.1182/blood-2025-654
View Full Paper
Ask AI
Bookmark
Share

Also Consider

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

  1. 1Phase I/II study of decitabine/cedazuridine (ASXT727), venetoclax, and gilteritinib for patients with FLT3-mutated Acute Myeloid Leukemia or high-risk myelodysplastic syndrome2025 · 2 citations
  2. 2Hypomethylating agents or chemotherapy in combination with venetoclax and gilteritinib for FLT3-mutated Acute Myeloid Leukemia2025 · 1 citations
  3. 3Venetoclax combined with three-day multi-frequency decitabine (DEC3-VEN) VS venetoclax combined with azacitidine in elderly patients with Acute Myeloid Leukemia：a phase III, prospective, multicenter, randomized controlled trial2025 · 1 citations
  4. 4Venetoclax in the treatment of acute myeloid leukemia: Beyond <scp>VIALE‐A</scp>2024 · 3 citations
  5. 5Efficacy 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