# AALL0232

Source: https://onco.cc/trials/aall0232/  
OnCo record `aall0232` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

AALL0232 showed that giving children with high-risk acute lymphoblastic leukaemia high doses of methotrexate with leucovorin rescue cured more of them than the older escalating schedule, and that the steroid dexamethasone helped children under ten but caused bone damage without benefit in older patients.

## Summary

AALL0232 was the Children's Oncology Group phase 3 trial for high-risk B-cell acute lymphoblastic leukaemia, enrolling 3,154 patients aged 1 to 30 between 2004 and 2011, of whom 2,914 were randomised in a 2 by 2 design: dexamethasone for 14 days or prednisone for 28 days during induction, and high-dose methotrexate with leucovorin rescue or Capizzi escalating-dose methotrexate with pegaspargase during the first interim maintenance.

Interim monitoring showed the superiority of high-dose methotrexate and stopped enrolment in January 2011. Mature five-year event-free survival was 79.6 percent with high-dose methotrexate against 75.2 percent with Capizzi methotrexate, with fewer marrow and central nervous system relapses and no increase in acute toxicity. Children aged 1 to 9 given dexamethasone and high-dose methotrexate did best, while patients aged 10 and over gained nothing from dexamethasone and had more osteonecrosis. High-dose methotrexate became the standard for high-risk childhood disease, which is how the corpus's high-risk childhood leukaemia page cites the trial.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-22
- Also known as: COG AALL0232
- Tags: soc-trials
- Registry id: NCT00075725
- Phase: 3
- Setting: Newly diagnosed high-risk B-cell acute lymphoblastic leukaemia in patients aged 1 to 30: a 2 by 2 randomisation of dexamethasone or prednisone during induction and high-dose methotrexate or Capizzi escalating methotrexate with pegaspargase during interim maintenance
- Sponsor: Children's Oncology Group
- Enrolled: 3154
- Result: Five-year event-free survival 79.6 percent with high-dose methotrexate against 75.2 percent with Capizzi methotrexate; dexamethasone benefited children aged 1 to 9 (five-year event-free survival 91.2 percent with high-dose methotrexate) but not older patients.
- Outcomes: Event-free survival at 5 years, methotrexate randomisation (mature data): High-dose methotrexate with leucovorin rescue 79.6% vs Capizzi escalating methotrexate with pegaspargase 75.2%; Event-free survival at 5 years, patients aged 1 to 9 by regimen: Dexamethasone + high-dose methotrexate 91.2% vs Dexamethasone + Capizzi methotrexate 83.2% vs Prednisone + high-dose methotrexate 80.8% vs Prednisone + Capizzi methotrexate 82.1%; Event-free survival at 5 years, patients aged 10 and over (registry results): Dexamethasone + high-dose methotrexate 77% vs Dexamethasone + Capizzi methotrexate 69.1% vs Prednisone + high-dose methotrexate 75.8% vs Prednisone + Capizzi methotrexate 73.5%

## Sources

- ClinicalTrials.gov NCT00075725: https://clinicaltrials.gov/study/NCT00075725

## Connected records

- cancers: [Acute lymphoblastic leukaemia](https://onco.cc/cancers/all-leukemia/), [High-risk acute lymphoblastic leukaemia in children (high-risk B-ALL and T-ALL)](https://onco.cc/cancers/all-paediatric-high-risk/), [Leukaemia (all types)](https://onco.cc/cancers/leukaemia/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [Asparaginase (pegaspargase, calaspargase pegol, Erwinia asparaginase)](https://onco.cc/drugs/asparaginase/), [Dexamethasone](https://onco.cc/drugs/dexamethasone/), [Methotrexate](https://onco.cc/drugs/methotrexate/), [Prednisone](https://onco.cc/drugs/prednisone/)
- institutions: [Children's Oncology Group (COG)](https://onco.cc/institutions/childrens-oncology-group/)
- key papers: [AALL0232: dexamethasone and high-dose methotrexate improve outcome in high-risk B-cell acute lymphoblastic leukaemia in children and young adults](https://onco.cc/key-papers/paper-aall0232-larsen-jco-2016/)

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