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December 8, 2025BloodOpen Access

Phase II study of clinical efficacy of venetoclax in combination with azacitidine in patients with therapy related myelodysplastic syndrome (t-MDS)

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Authors

UBUma BorateSHShivani HandaCLCurtis A. Lachowiez

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Overview

Interim results demonstrate clinical efficacy of venetoclax with azacitidine in t-MDS patients, indicating potential as a treatment option.

Key Points

  • To evaluate the safety and efficacy of venetoclax combined with azacitidine in patients with therapy-related myelodysplastic syndrome (t-MDS).
  • Single-arm, multi-center, open-label phase II trial
  • Enrolled adults aged 18+ with newly diagnosed t-MDS
  • Azacitidine at 75 mg/m2 for 7 days; Venetoclax 400 mg daily on days 1-14 for each 28-day cycle
  • Endpoints included complete remission rate and treatment-emergent adverse events
  • Response analyzed using Kaplan-Meier method for survival outcomes.
  • Overall response rate of 56.5% with 21.7% achieving complete remission by IWG 2023 criteria
  • Median overall survival of 10 months; responders had a median of 14.75 months
  • 39% of patients progressed to acute myeloid leukemia
  • 91% experienced severe treatment-emergent adverse events, primarily hematological complications
  • Combination therapy shows potential as a bridge to transplant for high-risk t-MDS patients.

Cite This Study

Borate et al. (2025) studied this question.

synapsesocial.com/papers/69362f5d4fa91c937236dc6dhttps://doi.org/10.1182/blood-2025-238
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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 trial of azacitidine and venetoclax in previously untreated Myelodysplastic Syndromes2025 · 1 citations
  2. 2Venetoclax and azacytidine in childhood primary advanced myelodysplastic syndromes, refractory/relapsed Acute Myeloid Leukemia and therapy-related myeloid diseases2025
  3. 3A phase 1b study of venetoclax and azacitidine combination in patients with relapsed or refractory myelodysplastic syndromes2022 · 77 citations
  4. 4Azacitidine combined with Venetoclax for pre-emptive treatment of AML/MDS after allogeneic stem cell transplantation: A prospective phase II study2025
  5. 5A pre-emptive bridge-to-transplant therapy for measurable residual disease with venetoclax and azacitidine in NPM1-mutated Acute Myeloid Leukemia: Updates from the ongoing GIMEMA AML2521 phase 2 trial2025