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Immunochemotherapy has become the standard of care for patients with Burkitt lymphoma. To prospectively assess the efficacy and safety of adding rituximab to such regimens, French investigators conducted an industry-funded, multicenter, randomized, controlled, open-label, phase III trial involving 260 HIV-negative, previously untreated Burkitt lymphoma patients older than 18 years.
Patients were stratified by the presence of limited versus extensive disease, the latter based on the absence or presence of bone marrow or central nervous system (CNS) involvement. All patients received multiagent chemotherapy with or without four doses of rituximab during the first two cycles of therapy, plus either CNS prophylaxis or treatment for active CNS in…