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December 8, 2025BloodOpen Access

Phase II trial of venetoclax in combination with azacitidine as maintenance therapy for high-risk acute leukemia following allogeneic stem cell transplantation

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Authors

BOBetül OranGAGheath AlatrashRBRoland L. Bassett

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Overview

Phase II trial shows improved safety and efficacy post-transplant in high-risk acute leukemia, suggesting benefits of venetoclax and azacitidine.

Key Points

  • To evaluate the safety and efficacy of venetoclax and azacitidine as maintenance therapy post-allogeneic transplant in high-risk acute leukemia.
  • Single-center, open-label Phase II clinical trial
  • Involvement of four high-risk cohorts
  • Assessment of safety and efficacy of VEN and AZA treatment
  • 63.3% relapse-free survival at 1 year
  • 56% overall survival at 2 years
  • Common grade 3-4 toxicities included neutropenia and anemia

Cite This Study

Oran et al. (2025) studied this question.

synapsesocial.com/papers/69362f7f4fa91c937236e538https://doi.org/10.1182/blood-2025-2511
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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 trial of venetoclax in combination with azacitidine as maintenance therapy for acute lymphoblastic leukemia following allogeneic stem cell transplantation2025
  2. 2Venetolax plus azacitidine is effective maintenance therapy after allogeneic hematopoietic stem cell transplantation in patients with intermediate/high-risk Acute Myeloid Leukemia2025
  3. 3Azacitidine combined with Venetoclax for pre-emptive treatment of AML/MDS after allogeneic stem cell transplantation: A prospective phase II study2025
  4. 4Real-life multicenter experience of long-term treatment with venetoclax plus azacitidine for acute myeloid leukemia in China2026
  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