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December 8, 2025BloodOpen Access

Azacitidine combined with Venetoclax for pre-emptive treatment of AML/MDS after allogeneic stem cell transplantation: A prospective phase II study

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Authors

LLLizhen LiuXLXiaoyu LaiLYLuxin Yang

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Overview

Prospective phase II study shows azacitidine plus venetoclax improves progression-free survival in AML/MDS post-transplant, suggesting effective management of MRD.

Key Points

  • This study aimed to evaluate the efficacy of MRD-guided pre-emptive therapy using azacitidine combined with venetoclax in AML/MDS patients post-transplantation.
  • Patients with AML or MDS after allo-HSCT were screened for MRD using multiflow cytometry and PCR methods.
  • MRD-positive patients received azacitidine and venetoclax for six cycles, administered every 4-8 weeks.
  • Response to treatment was assessed using specific criteria for major and minor responses.
  • Major response rate reached 62.8% after the first cycle and peaked at 67.4% by the third cycle.
  • A total of 40.9% of patients relapsed within a median follow-up of 549 days, with a 2-year cumulative incidence of relapse of 46.4%.
  • At 2 years, overall survival was 73.5% and progression-free survival was 48.6% with manageable adverse events.

Cite This Study

Liu et al. (2025) studied this question.

synapsesocial.com/papers/69362f4b4fa91c937236d76chttps://doi.org/10.1182/blood-2025-1061
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Also Consider

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

  1. 1A 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
  2. 2A phase I/II trial of azacitidine and venetoclax in previously untreated Myelodysplastic Syndromes2025 · 1 citations
  3. 3The venetoclax combined with metronomic low-dose decitabine and interferon for preventing post-transplant relapse in high-risk MDS and AML patients2025
  4. 4Phase II trial of venetoclax in combination with azacitidine as maintenance therapy for high-risk acute leukemia following allogeneic stem cell transplantation2025
  5. 5Phase II study of clinical efficacy of venetoclax in combination with azacitidine in patients with therapy related myelodysplastic syndrome (t-MDS)2025