Inter-B-NHL Ritux 2010
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.
Overview
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.
- 93.9 vs 82.3 out of 100 free of a major event at 3 years with Rituximab + LMB chemotherapy compared with LMB chemotherapy; 11.6 more per 100.
- Roughly one extra person helped for every 9 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 68 percent lower chance of the event at any given time (hazard ratio 0.32, likely range 0.15 to 0.66).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: High-risk mature B-cell non-Hodgkin lymphoma or B-acute leukaemia in patients under 18 (mostly Burkitt lymphoma): LMB chemotherapy with or without six doses of rituximab. People in a different situation may not see the same effect.
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 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| 3-year event-free survivalprimary | Rituximab + LMB chemotherapy | 164 | 93.9% | 0.32 (0.15–0.66) | 0.00096 (one-sided) | link |
| LMB chemotherapy | 164 | 82.3% |
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