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Adding the antibody rituximab to intensive chemotherapy in children with high-risk Burkitt and related lymphomas cut treatment failures by about two-thirds, making an already curable disease more so. It is the model of a joint European-North American children's cancer trial.
Open-label international randomised phase 3 (Minard-Colin et al., NEJM 2020). Among 328 randomised patients (164 per arm; 85.7% Burkitt lymphoma), events occurred in 10 with rituximab-chemotherapy versus 28 with chemotherapy alone. Three-year event-free survival was 93.9% (95% CI 89.1 to 96.7) versus 82.3% (95% CI 75.7 to 87.5), HR 0.32 (95% CI 0.15 to 0.66), and overall survival also improved. Randomisation was stopped early for efficacy and all subsequent patients received rituximab. Rituximab roughly doubled the rate of hypogammaglobulinaemia and increased infections, so immune monitoring is part of follow-up. Rituximab plus LMB is now the standard for high-risk paediatric mature B-cell lymphoma on both sides of the Atlantic and formed the basis of the 2021 FDA paediatric label extension for rituximab.
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.
482 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| 3-year event-free survivalprimary | Rituximab + LMB chemotherapy | 164 | 93.9% | 0.32 (0.15 to 0.66) | 0.00096 (one-sided) | link |
| LMB chemotherapy | 164 | 82.3% |
Shares Cytarabine + anthracycline ('7+3'), Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Children's Oncology Group (COG) and the tags paediatric, haematologic.
Shares SIOP Europe (European Society for Paediatric Oncology), Children's Oncology Group (COG) and the tags paediatric, haematologic.
Shares SIOP Europe (European Society for Paediatric Oncology), Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Methotrexate, Children's Oncology Group (COG) and the tag paediatric.
Shares Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Children's Oncology Group (COG), Vincristine, Etoposide and the tag paediatric.
Shares SIOP Europe (European Society for Paediatric Oncology), Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first and the tag paediatric.
Shares Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Children's Oncology Group (COG), Vincristine, Etoposide and the tag paediatric.
Shares CD20, Rituximab, Monoclonal antibodies and the tag haematologic.
Shares Children's Oncology Group (COG), Vincristine, Doxorubicin and the tag paediatric.