Synapse
⌘+K
Synapse
PulseExploreClubsResearchersJournals
Instagram
HomeClubsExplore
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

View Full Paper
Ask AI
Bookmark
Share

Authors

FBFrancisco BautistaJLJennifer LukinFGFaith Galderisi

Discussion

Loading...

Member takes

Overview

Randomized trial examines overall survival in children with relapsed acute myeloid leukemia using venetoclax and chemotherapy, suggesting new treatment options.

Key Points

  • To compare overall survival in pediatric patients receiving venetoclax with fludarabine and gemtuzumab ozogamycin versus fludarabine and gemtuzumab ozogamycin alone.
  • Open-label, randomized phase 3 trial of patients aged >28 days to <22 years with relapsed AML.
  • Patients randomized to receive chemotherapy with or without venetoclax.
  • Primary analysis to assess overall survival at five years post-randomization.
  • 71 patients enrolled across 80 sites in multiple countries with ongoing recruitment.
  • 46% of patients enrolled had late first relapse; higher than anticipated.
  • Monitoring for safety and adverse events implemented with no early stopping rules triggered.

Cite This Study

Bautista et al. (2025) studied this question.

synapsesocial.com/papers/69362f764fa91c937236e39fhttps://doi.org/10.1182/blood-2025-1656
View Full Paper
Ask AI
Bookmark
Share

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. 4Targeting Molecular Measurable Residual Disease and Low-Blast Relapse in AML With Venetoclax and Low-Dose Cytarabine: A Prospective Phase II Study (VALDAC)2024 · 30 citations
  5. 5Safety 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