Phase II Study of "VIPER" Chemotherapy in Rel/Ref DLBCL
Status:
Completed
Trial end date:
2012-02-17
Target enrollment:
Participant gender:
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