# COG AALL0434

Source: https://onco.cc/trials/aall0434/  
OnCo record `aall0434` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

AALL0434 was the largest trial ever run in childhood T-cell leukaemia; it showed that adding the drug nelarabine to standard chemotherapy cut relapses, and that most children could be cured without radiation to the brain.

## Summary

The Children's Oncology Group trial AALL0434 enrolled 1895 patients aged 1 to 30 with newly diagnosed T-cell acute lymphoblastic leukaemia or T-lymphoblastic lymphoma. Intermediate- and high-risk patients were randomised in a two-by-two design to augmented Berlin-Frankfurt-Munster chemotherapy with or without six courses of nelarabine, and to Capizzi escalating-dose methotrexate with pegaspargase or to high-dose methotrexate.

Nelarabine improved disease-free survival in T-cell leukaemia, with fewer central nervous system relapses, and the Capizzi methotrexate arm outperformed high-dose methotrexate. Cranial irradiation was omitted for all but the highest-risk group without excess central nervous system relapse. Overall survival across the trial was the best yet reported for T-cell leukaemia, and nelarabine became part of front-line therapy for higher-risk disease.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Also known as: AALL0434
- Tags: subtype-trials
- Registry id: NCT00408005
- Phase: 3
- Setting: Newly diagnosed T-cell acute lymphoblastic leukaemia and lymphoblastic lymphoma in children and young adults: augmented BFM chemotherapy with or without nelarabine, and Capizzi-style escalating methotrexate against high-dose methotrexate
- Sponsor: Children's Oncology Group (National Cancer Institute)
- Enrolled: 1895
- Result: Nelarabine improved disease-free survival in T-cell acute lymphoblastic leukaemia, and Capizzi methotrexate outperformed high-dose methotrexate.

## Sources

- ClinicalTrials.gov NCT00408005: https://clinicaltrials.gov/study/NCT00408005

## 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/)
- drugs: [Methotrexate](https://onco.cc/drugs/methotrexate/), [Nelarabine](https://onco.cc/drugs/nelarabine/)
- people: [Kimberly P. Dunsmore](https://onco.cc/people/kimberly-dunsmore/)
- key papers: [AALL0434: nelarabine in newly diagnosed T-cell acute lymphoblastic leukaemia in children and young adults](https://onco.cc/key-papers/paper-aall0434-nelarabine-t-all-dunsmore-jco-2020/)

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