Phase II Study of "VIPER" Chemotherapy in Rel/Ref DLBCL

Summary

Objectives The primary objective of this study is to: • determine the complete and partial response rates and the toxicity profile of bortezomib (VELCADE, formerly PS-341) when administered in combination with DICE chemotherapy plus rituximab (i.e. VIPER) to patients with relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma The secondary objectives of this study are to: * assess event free survival and overall survival * assess conversion of chemo-resistant to chemo-sensitive disease * assess the ability to collect stem cells from patients treated with salvage VIPER who then undergo autologous stem cell transplantation * perform correlative studies on pre-treatment tumor biopsy specimens; analyses will include the assessment of immunohistochemical expression patterns (germinal center B cell vs. activated B cell) and NF-κB activity

Timeline

Start

2007-05

Primary completion

2010-12

Completion

2012-02-17

Drugs

Indications