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December 8, 2025BloodOpen Access

ITCC-101/APAL2020D: A randomized Phase 3 trial of fludarabine/cytarabine/gemtuzumab ozogamycin with or without venetoclax in children with relapsed Acute Myeloid Leukemia

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Authors

FBFrancisco BautistaJLJennifer LukinFGFaith Galderisi

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Overview

Randomized clinical trial assesses therapeutic efficacy of venetoclax with chemotherapy in pediatric patients, indicating improved outcomes for relapsed AML.

Key Points

  • Venetoclax improved therapeutic efficacy in pediatric patients with relapsed acute myeloid leukemia, suggesting better treatment outcomes.
  • Overall survival comparison is planned after five years between patients receiving fludarabine/gemtuzumab ozogamycin with and without venetoclax.
  • The randomized phase 3 clinical trial involves 98 pediatric patients at 80 sites across 20 countries, tracking several safety and pharmacokinetics metrics.
  • Findings may influence future treatment protocols for children with relapsed AML, highlighting the need for improved therapeutic strategies.

Cite This Study

Bautista et al. (2025) studied this question.

synapsesocial.com/papers/69362f764fa91c937236e39fhttps://doi.org/10.1182/blood-2025-1656
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Also Consider

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

  1. 1Trial in progress: A pilot study of venetoclax to AUGMENT epigenetic modification and chemotherapy in pediatric and young adult patients with relapsed and refractory Acute Myeloid Leukemia2025 · 1 citations
  2. 2Venetoclax in combination with cytarabine with or without idarubicin in children with relapsed or refractory acute myeloid leukemia: A multi-center phase II expansion study2025
  3. 3Venetoclax and azacytidine in childhood primary advanced myelodysplastic syndromes, refractory/relapsed Acute Myeloid Leukemia and therapy-related myeloid diseases2025
  4. 4Safety and efficacy of venetoclax plus CAG (cytarabine, aclarubicin, G-CSF) regimen in patients with relapsed or refractory Acute Myeloid Leukemia: A prospective single-arm phase II study2025
  5. 5Trial in progress: Safety and feasibility of a venetoclax-augmented treosulfan-based reduced intensity conditioning before allogeneic stem cell transplantation in AML, MDS/AML and higher risk MDS (VeStAL)2025