N Engl J Med 2018 Mar;378(12):1107-1120
From the Peter MacCallum Cancer Centre, Royal Melbourne Hospital, and University of Melbourne, Melbourne, VIC (J.F.S.), and the John Curtin School of Medical Research, Australian National University, Canberra, ACT (J.D.) - all in Australia; the University of California School of Medicine, San Diego (T.J.K.), and Genentech, South San Francisco (E.A.P., Y.L., M. Mobasher) - both in California; University Hospital Cologne and the Center for Integrated Oncology Cologne-Bonn, Cologne, Germany (B.E.); St. James's University Hospital, Leeds (P.H.), and F. Hoffmann-La Roche, Welwyn Garden City (M.B., K.H.) - both in the United Kingdom; Segal Cancer Center, Lady Davis Institute, Jewish General Hospital, Montreal (S.A.), and the Departments of Medicine and Oncology, University of Calgary, Calgary, AB (C.O.) - all in Canada; Memorial Sloan Kettering Cancer Center, New York (J.G.); the Department of Hematology, Medical University of Lodz and Copernicus Memorial Hospital, Lodz, Poland (T.R.); Hospital Universitario 12 de Octubre, Madrid (J.D.S.); Medical University of Vienna, Department of Medicine I, Division of Hematology and Hemostaseology, Vienna (U.J.); the Department of Hematology, Centre Hospitalier Universitaire Montpellier, Montpellier, France (G.C.); the Department of Onco-Hematology, Division of Hematology, Niguarda Cancer Center, Niguarda Hospital, Milan (M. Montillo); AbbVie, North Chicago, IL (R.H.); and the Department of Hematology, Cancer Center Amsterdam, Academic Medical Center, Amsterdam (A.P.K.).
Background: Venetoclax inhibits BCL2, an antiapoptotic protein that is pathologically overexpressed and that is central to the survival of chronic lymphocytic leukemia cells. We evaluated the efficacy of venetoclax in combination with rituximab in patients with relapsed or refractory chronic lymphocytic leukemia.
Methods: In this randomized, open-label, phase 3 trial, we randomly assigned 389 patients to receive venetoclax for up to 2 years (from day 1 of cycle 1) plus rituximab for the first 6 months (venetoclax-rituximab group) or bendamustine plus rituximab for 6 months (bendamustine-rituximab group). Read More