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Bortezomib in combination with dexamethasone for patients with relapsed Hodgkin’s lymphoma: results of a prematurely closed phase II study (NCT00148018)

Sven Trelle^*,°, Orhan Sezer^#, Ralph Naumann^@, Mathias Rummel^{^}, Ulrich Keller, Andreas Engert^*, Peter Borchmann^*,

^* Department I of Internal Medicine, University of Cologne, Germany
^° Department of Social and Preventive Medicine, University of Berne, Switzerland;
^# Department of Internal Medicine II, Charité Campus Mitte Berlin, Germany
^@ Department of Internal Medicine I, Technical University Dresden, Germany
^{^} Department of Internal Medicine II, University of Frankfurt, Germany
Department of Internal Medicine III, Technical University Munich, Germany

Correspondence: Peter Borchmann, Klinik I für Innere Medizin, Klinikum der Universität zu Köln, 50924 Köln, Germany. Phone: international +41.221.478-5933. E-mail: peter.borchmann{at}uni-koeln.de

We conducted a two-stage phase II study to investigate the activity of bortezomib and dexamethasone in patients with relapsed Hodgkin’s lymphoma. The study was prematurely closed after the first stage with twelve enrolled patients because no response was observed. A meta-analysis of all four available studies evaluating bortezomib in this population showed no activity of bortezomib (combined response rate: 0.03; 95%-CI: 0.01 to 0.12).

Key words: bortezomib, Hodgkin’s disease, lymphoma, phase II clinical trial, recurrence.

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