Phase II Study of Ofatumumab Plus ICE or DHAP Chemotherapy Regimen in Relapsed/ Refractory DLBCL

Status:	Archived
Conditions:	Lymphoma
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	May 2009
End Date:	December 2011

A Single Arm, Safety and Efficacy Study of Ofatumumab in Combination With ICE or DHAP Chemotherapy in Relapsed or Refractory Aggressive Lymphoma Prior to Autologous Stem Cell Transplantation

The purpose of this study is to evaluate the safety and efficacy of ofatumumab used in
combination with ICE or DHAP salvage chemotherapy regimens in subjects with relapsed or
refractory DLBCL who are eligible for autologous stem cell transplant.

Rituximab combined with anthracycline based chemotherapy is the most common first-line
treatment for subjects with diffuse large B cell lymphoma (DLBCL). Subjects requiring
second-line therapy will most often receive rituximab in combination with salvage
chemotherapy as an induction therapy prior to autologous stem cell transplant. With
rituximab being in first-line therapy, the response rates for subjects receiving rituximab
plus salvage chemotherapy has significantly decreased. Treatment with ofatumumab may be
able to overcome the resistance to rituximab in the second-line setting and offer improved
response rates. The objective of this study is to evaluate the overall response rate of
ofatumumab in combination with ICE or DHAP chemotherapy prior to autologous stem cell
transplant. Additional objectives are to evaluate the complete response rate, ability to
mobilize CD34+ cells, progression-free survival (PFS) and overall survival.

We found this trial at

sites

McFarland Clinic, PC

Ames, Iowa 50010