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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.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,440 randomised.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Disease-free survival at 3 yearsprimary | Blinatumomab + chemotherapy | 722 | 96% | 0.39 (0.24 to 0.64) | <0.001 | link |
| Chemotherapy | 718 | 87.9% |
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares Blinatumomab added to frontline chemotherapy, Standard-risk B-cell acute lymphoblastic leukaemia in children, Blinatumomab, CD3.
Shares Blinatumomab, CD3, Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, CD19.
Shares Blinatumomab added to frontline chemotherapy, Children's Oncology Group AALL1731: blinatumomab added to chemotherapy for children with standard-risk B-cell ALL, Blinatumomab, CD3.
Shares Standard-risk B-cell acute lymphoblastic leukaemia in children, Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Children's Oncology Group (COG), Rare and paediatric cancers without markets.
Shares Blinatumomab, CD3, CD19, T-cell engagers (bispecific).
Shares Blinatumomab, Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Rare and paediatric cancers without markets, T-cell engagers (bispecific).
Shares Blinatumomab, CD19, T-cell engagers (bispecific), Acute lymphoblastic leukaemia.
Shares Blinatumomab, CD3, CD19, Acute lymphoblastic leukaemia.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/