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
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 cluster of differentiation (CD)34+ cells, progression-free survival (PFS) and
overall survival.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Overall Response (OR), as Assessed by the Investigator
Responders with OR included participants with complete response (CR) and partial response (PR). This was based on adequate responses from the investigator assessment after the completion of treatment. CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR: at least a 50% decrease from baseline in the sum of the product of the diameters of target lesions.
From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3
No
GSK Clinical Trials
Study Director
GlaxoSmithKline
United States: Institutional Review Board
110927
NCT00823719
May 2009
September 2011
Name | Location |
---|