# COG AALL1731

Source: https://onco.cc/trials/aall1731/  
OnCo record `aall1731` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

In children with average-risk leukaemia, adding blinatumomab pushed three-year disease-free survival from 88% to 96%, one of the largest gains in decades.

## Summary

1,440 randomised children with standard-risk average or high subsets. 3-year DFS 96.0% vs 87.9% (HR 0.39, 95% CI 0.24-0.64); randomisation stopped early for efficacy. NEJM 2024. Led to FDA approval of blinatumomab in the consolidation phase for CD19+ Ph-negative B-ALL in children (June 2024) and is being adopted as the new paediatric standard.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT03914625
- Phase: 3
- Setting: Newly diagnosed standard-risk B-ALL in children: two cycles of blinatumomab added to chemotherapy vs chemotherapy alone
- Sponsor: Children's Oncology Group / NCI
- Enrolled: 1440
- Result: 3-year DFS 96.0% vs 87.9%; HR 0.39.
- Outcomes: Disease-free survival at 3 years: Blinatumomab + chemotherapy 96% vs Chemotherapy 87.9%, HR 0.39
- Replication: Consistent with E1910 in adults; the paediatric MRD-positive blinatumomab trials (AALL1331, IntReALL HR 2010) had shown benefit in relapse earlier.

## Sources

- ClinicalTrials.gov NCT03914625: https://clinicaltrials.gov/study/NCT03914625
- NEJM 2024: https://www.nejm.org/doi/full/10.1056/NEJMoa2411680

## Connected records

- cancers: [Acute lymphoblastic leukaemia](https://onco.cc/cancers/all-leukemia/), [Standard-risk B-cell acute lymphoblastic leukaemia in children](https://onco.cc/cancers/all-paediatric-standard-risk/)
- technologies: [T-cell engagers (bispecific)](https://onco.cc/technologies/t-cell-engager/)
- targets: [CD19](https://onco.cc/targets/cd19/), [CD3](https://onco.cc/targets/cd3/)
- drugs: [Blinatumomab](https://onco.cc/drugs/blinatumomab/), [Crisantaspase (recombinant Erwinia asparaginase)](https://onco.cc/drugs/crisantaspase/)
- companies: [Children's Oncology Group (COG)](https://onco.cc/companies/childrens-oncology-group/)
- people: [Rachel E. Rau](https://onco.cc/people/rachel-rau/), [Stephen P. Hunger](https://onco.cc/people/stephen-hunger/), [Sumit Gupta](https://onco.cc/people/sumit-gupta/)
- pairings: [Blinatumomab added to frontline chemotherapy](https://onco.cc/pairings/blinatumomab-frontline-consolidation/)
- bottlenecks: [Rare and paediatric cancers without markets](https://onco.cc/bottlenecks/b-rare-cancers/)
- key papers: [Children's Oncology Group AALL1731: blinatumomab added to chemotherapy for children with standard-risk B-cell ALL](https://onco.cc/key-papers/paper-aall1731-blinatumomab-children-nejm-2025/)
- roadmaps: [Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first](https://onco.cc/roadmaps/paediatric-oncology-roadmap/)

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