Clinical Trial, Phase II; Comparative Study; Letter; Multicenter Study; Research Support, Non-U.S. Gov't; Letter
Trelle, S; Sezer, O; Naumann, R; Rummel, M; Keller, U; Engert, A; Borchmann, P
Bortezomib in combination with dexamethasone for patients with relapsed Hodgkin's lymphoma: results of a prematurely closed phase II study (NCT00148018).
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).