Rituximab and dose-dense chemotherapy for adults with Burkitt's lymphoma: a randomised, controlled, open-label, phase 3 trial

Publication date: Available online 11 April 2016 Source:The Lancet Author(s): Vincent Ribrag, Serge Koscielny, Jacques Bosq, Thibaut Leguay, Olivier Casasnovas, Luc-Mathieu Fornecker, Christian Recher, Hervé Ghesquieres, Franck Morschhauser, Stéphane Girault, Steven Le Gouill, Mario Ojeda-Uribe, Clara Mariette, Jerome Cornillon, Guillaume Cartron, Veronique Verge, Catherine Chassagne-Clément, Hervé Dombret, Bertrand Coiffier, Thierry Lamy, Hervé Tilly, Gilles Salles Background Short intensive chemotherapy is the standard of care for adult patients with Burkitt's leukaemia or lymphoma. Findings from single-arm studies suggest that addition of rituximab to these regimens could improve patient outcomes. Our objective was to test this possibility in a randomised trial. Methods In this randomised, controlled, open-label, phase 3 trial, we recruited patients older than 18 years with untreated HIV-negative Burkitt's lymphoma (including Burkitt's leukaemia) from 45 haematological centres in France. Exclusion criteria were contraindications to any drug included in the chemotherapy regimens, any serious comorbidity, poor renal (creatinine concentration >150 μmol/L) or hepatic (cirrhosis or previous hepatitis B or C) function, pregnancy, and any history of cancer except for non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma. Patients were stratified into two groups based on disease extension (absence [group B]...
Source: The Lancet - Category: Journals (General) Source Type: research