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December 8, 2025BloodOpen Access

A phase I/II trial of azacitidine and venetoclax in previously untreated Myelodysplastic Syndromes

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Authors

IBIan M. BoulignyWJWei‐Ying JenEKEitan Kugler

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Overview

Phase I/II trial reveals high response rates in patients with high-risk MDS, indicating effective therapy with azacitidine and venetoclax.

Key Points

  • Azacitidine and venetoclax produce high response rates, with an overall response rate of 93% in high-risk myelodysplastic syndromes.
  • Patients reached median overall survival of 16.1 months, highlighting the significance of treatment in this population.
  • The trial utilized a phase 1/2 design assessing azacitidine and venetoclax in treatment-naïve patients with high-risk disease.
  • Improved outcomes associated with molecular profiles, particularly in individuals with TP53 mutations, underscore potential targeted therapeutic strategies.

Cite This Study

Bouligny et al. (2025) studied this question.

synapsesocial.com/papers/69362f4e4fa91c937236d895https://doi.org/10.1182/blood-2025-5647
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Also Consider

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

  1. 1Phase II study of clinical efficacy of venetoclax in combination with azacitidine in patients with therapy related myelodysplastic syndrome (t-MDS)2025
  2. 2Azacitidine combined with Venetoclax for pre-emptive treatment of AML/MDS after allogeneic stem cell transplantation: A prospective phase II study2025
  3. 3Oral decitabine/cedazuridine in combination with venetoclax in treatment-naïve high-risk myelodysplastic syndrome or chronic myelomonocytic leukemia: Updates of a Phase 1/2 clinical trial2025 · 2 citations
  4. 4Venetoclax and azacytidine in childhood primary advanced myelodysplastic syndromes, refractory/relapsed Acute Myeloid Leukemia and therapy-related myeloid diseases2025
  5. 5Phase I study of lower dose CPX-351 combined with venetoclax for patients with higher-risk myelodysplastic syndrome or chronic myelomonocytic leukemia after hypomethylating agents failure2025