The addition of rituximab to the chemotherapy backbone was shown to significantly improve outcomes of children with aggressive high-grade lymphomas in high-income countries. However, data on its safety, and efficacy in children with Epstein-Barr-Virus-positive Burkitt lymphoma (EBV-positive BL) are limited. We conducted a prospective non-randomized observational study in East African patients up to the age of 25 years with confirmed BL. Patients received either the INCTR-based Standard Chemotherapy (COM) or Rituximab plus standard chemotherapy (R-COM). The primary endpoint was safety. The secondary outcomes were event-free and overall survival and cost-effectiveness of incorporating rituximab. Primary analyses were conducted in the intention-to-treat population. The median follow-up was 23 months. Safety analyses included 72 patients: 32 in the COM group and 42 in the R-COM group. Grade 3 or higher adverse events occurred in 18% of R-COM patients and 16% of COM patients. With respect to treatment outcomes at 12 months, 5 events were observed in the R-COM group and 14 in the COM group. The 12-month event-free survival was 67% with R-COM and 43% with COM (hazard ratio, 0·49
95% CI, 0·24-0·98
P=0·045). There were eight deaths in the R-COM group, while in the COM group, 16 patients died (hazard ratio, 0·32
95% CI, 0·14-0·75, P=0·009). R-COM was particularly effective in advanced-stage disease. The addition of rituximab to the INCTR-based protocol (COM) for EBV-positive BL has been observed to be safe and feasible in experienced centres in East Africa and saves lives.