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December 8, 2025BloodOpen Access

A 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 trial

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Authors

GMGiovanni MarsiliPFPaola FaziMTMario Tiribelli

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Overview

Phase 2 trial shows venetoclax-azacitidine maintains remission in NPM1m AML, suggesting effective transplant bridging.

Key Points

  • To evaluate the efficacy of venetoclax-azacitidine in preventing relapse and improving outcomes in NPM1-mutated AML patients.
  • Phase 2, open-label trial with 35 adult NPM1-mutated AML patients
  • Intervention incorporates venetoclax and azacitidine during treatment and monitoring
  • Participants defined as molecularly relapsed or progressing with centralized MRD positivity
  • 96% of patients maintained complete remission during treatment
  • MRD negativity achieved in 80% of patients
  • 84% of patients bridged to allogeneic stem cell transplantation without relapse

Cite This Study

Marsili et al. (2025) studied this question.

synapsesocial.com/papers/69362f7f4fa91c937236e562https://doi.org/10.1182/blood-2025-3516
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