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July 30, 2026Blood

OPTI-AML: Prospective Comparison of 28 vs.14 days of Venetoclax Induction with Azacitidine in Older Adults with AML

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Authors

UBUma BorateYHYing HuangTLTara L. Lin

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Overview

Randomized trial compares complete remission rates of different venetoclax durations in older adults with AML, suggesting treatment may vary in effectiveness for specific mutations.

Key Points

  • This trial aims to compare the efficacy and safety of a 14-day versus a 28-day venetoclax schedule in older adults with newly diagnosed acute myeloid leukemia.
  • Prospective randomized trial (NCT03013998) involving 169 patients with ND-AML aged ≥60 years.
  • Patients received either 28-day or 14-day venetoclax dosing alongside azacitidine.
  • The primary endpoint focused on complete remission rates after two cycles of therapy.
  • Complete remission rates were 49.4% for the 28-day group and 43% for the 14-day group, not meeting non-inferiority criteria.
  • Patients with NPM1/IDH2 mutations showed higher remission rates with the 28-day regimen (60.9% vs. 33.3%).
  • Overall treatment interruption rates were higher in the 28-day group but adverse event rates were similar between both groups.

Cite This Study

Borate et al. (2026) studied this question.

synapsesocial.com/papers/6a6af4e960e2b924d3ea07c7https://doi.org/10.1182/blood.2026034611
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Also Consider

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

  1. 1Venetoclax combined with azacitidine in elderly acute myeloid leukemia: A retrospective comparison of 14-day vs 28-day dosing regimens2025 · 2 citations
  2. 2Tolerability and Outcomes With Serial Cycles of 28 Days of Venetoclax in Newly Diagnosed Patients With Acute Myeloid Leukemia2026
  3. 3Efficacy of a 14-day venetoclax regimen in combination with a hypomethylating agent for Acute Myeloid Leukemia: A single-center retrospective analysis2025
  4. 4Optimizing venetoclax duration with hypomethylating agents for newly diagnosed acute myeloid leukemia: impact on response and survival2026
  5. 5Addition of Venetoclax to Azacitidine Did Not Improve Survival in Acute Myeloid Leukemia and Was Not Well Tolerated: Real World Experience2026