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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

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Authors

APAlexander E. PerlYDYehuda E. DeutschMBMaria R. Baer

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Overview

Phase 1 trial found venetoclax 400mg significantly improves complete remission rates in patients with newly diagnosed FLT3mut+ AML, suggesting enhanced treatment viability.

Key Points

  • Venetoclax/azacitidine/gilteritinib achieved a complete remission rate of 70% in acute myeloid leukemia patients, showing promising efficacy.
  • Safety events occurred in 25% of patients receiving either dosing regimen, with adverse events primarily involving febrile neutropenia.
  • Analysis of pharmacokinetics revealed an increase in venetoclax exposure with dose; evaluating dose-response profile is essential.
  • Granulocyte colony-stimulating factor was mandated for patients with low absolute neutrophil counts, with ongoing phase 2 enrollment.

Cite This Study

Perl et al. (2025) studied this question.

synapsesocial.com/papers/69362f3a4fa91c937236d447https://doi.org/10.1182/blood-2025-654
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