# AALL1231

Source: https://onco.cc/trials/aall1231/  
OnCo record `aall1231` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

AALL1231 tried to improve treatment for T-cell leukaemia and lymphoma in children by adding bortezomib and by dropping routine radiotherapy to the brain; bortezomib clearly helped the lymphoma patients but not the whole group, and more than nine in ten children were spared cranial radiotherapy without more relapses.

## Summary

AALL1231 was the Children's Oncology Group phase 3 trial for newly diagnosed T-cell acute lymphoblastic leukaemia and T-lymphoblastic lymphoma. 824 eligible patients enrolled between 2014 and 2017 were randomised to a modified augmented Berlin-Frankfurt-Munster regimen with or without bortezomib during induction and delayed intensification. The backbone used dexamethasone in place of prednisone and added two pegaspargase doses so that prophylactic cranial radiotherapy could be omitted in most patients (only 9.5 percent were scheduled to receive it, against 90.8 percent in the predecessor AALL0434).

Four-year event-free survival was 80.1 percent without bortezomib and 83.8 percent with it, not a significant difference, and overall survival followed the same pattern. Patients with T-lymphoblastic lymphoma did significantly better with bortezomib (four-year event-free survival 86.4 against 76.5 percent, overall survival 89.5 against 78.3 percent) with no excess toxicity. Comparison with AALL0434 patients who had cranial radiotherapy showed no difference in event-free or overall survival, so the trial is cited as the evidence that cranial irradiation can be limited to central nervous system involvement and the highest-risk patients.

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-09-22
- Also known as: COG AALL1231
- Tags: soc-trials
- Registry id: NCT02112916
- Phase: 3
- Setting: Newly diagnosed T-cell acute lymphoblastic leukaemia and stage II to IV T-lymphoblastic lymphoma in children and young adults: a modified augmented BFM regimen with or without bortezomib during induction and delayed intensification, with prophylactic cranial radiotherapy removed for most patients
- Sponsor: National Cancer Institute (NCI)
- Enrolled: 847
- Result: Bortezomib did not significantly improve four-year event-free survival for the whole group (83.8 against 80.1 percent) but did for T-lymphoblastic lymphoma; cranial radiotherapy was removed for more than 90 percent of patients without excess relapse.
- Outcomes: Event-free survival at 4 years, all randomised patients: Modified augmented BFM + bortezomib 83.8% vs Modified augmented BFM 80.1%; Overall survival at 4 years, all randomised patients: Modified augmented BFM + bortezomib 88.3% vs Modified augmented BFM 85.7%; Event-free survival at 4 years, T-lymphoblastic lymphoma: Modified augmented BFM + bortezomib 86.4% vs Modified augmented BFM 76.5%; Overall survival at 4 years, T-lymphoblastic lymphoma: Modified augmented BFM + bortezomib 89.5% vs Modified augmented BFM 78.3%; Event-free survival at 3 years, all randomised patients (registry results): Modified augmented BFM + bortezomib 85.1% vs Modified augmented BFM 81.7%, HR 0.782

## Sources

- ClinicalTrials.gov NCT02112916: https://clinicaltrials.gov/study/NCT02112916

## 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/), [Bortezomib](https://onco.cc/drugs/bortezomib/), [Dexamethasone](https://onco.cc/drugs/dexamethasone/)
- institutions: [Children's Oncology Group (COG)](https://onco.cc/institutions/childrens-oncology-group/)
- key papers: [AALL1231: bortezomib in newly diagnosed T-cell acute lymphoblastic leukaemia and lymphoma, with cranial radiotherapy removed](https://onco.cc/key-papers/paper-aall1231-bortezomib-t-all-teachey-jco-2022/)

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