# AAML0531: gemtuzumab ozogamicin added to chemotherapy for children and adolescents with acute myeloid leukaemia

Source: https://onco.cc/key-papers/paper-aaml0531-gemtuzumab-gamis-jco-2014/  
OnCo record `paper-aaml0531-gemtuzumab-gamis-jco-2014` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Adding the CD33-targeted antibody-drug conjugate gemtuzumab ozogamicin to two courses of chemotherapy reduced relapses in childhood acute myeloid leukaemia, most clearly in the high-risk group, and it was later restored to the paediatric label.

## Summary

Phase 3 trial of 1,022 children, adolescents and young adults with newly diagnosed AML randomised to standard chemotherapy with or without gemtuzumab ozogamicin in induction and intensification.

Event-free survival at three years was 53.1 versus 46.9 percent (hazard ratio 0.83) with relapse risk reduced from 41 to 33 percent; overall survival was not significantly different (69.4 versus 65.4 percent), and benefit was greatest in high-risk patients and those with high CD33 expression.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: Journal of Clinical Oncology
- Year: 2014
- DOI: 10.1200/JCO.2014.55.3628
- Authors: Gamis AS, Alonzo TA, Meshinchi S, et al.
- Findings: Three-year event-free survival 53.1 percent vs 46.9 percent; relapse risk 32.8 percent vs 41.3 percent.; Overall survival 69.4 percent vs 65.4 percent (not significant).
- What it means: Gemtuzumab ozogamicin is part of standard induction for CD33-positive childhood AML in Children's Oncology Group protocols.
- Caveats: Higher treatment-related mortality offset part of the relapse reduction.; Benefit depends on CD33 expression and splicing genotype.

## Sources

- J Clin Oncol 2014: https://doi.org/10.1200/JCO.2014.55.3628
- PubMed: https://pubmed.ncbi.nlm.nih.gov/25092781/

## Connected records

- cancers: [Acute myeloid leukaemia in children](https://onco.cc/cancers/aml-paediatric/)
- drugs: [Gemtuzumab ozogamicin](https://onco.cc/drugs/gemtuzumab-ozogamicin/)
- trials: [COG AAML0531](https://onco.cc/trials/aaml0531/)
- journals: [Journal of Clinical Oncology](https://onco.cc/journals/jco/)

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