Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant (ASCT) in Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
As rituximab-based regimens have become standard first-line treatment in CD20 positive
DLBCL, the efficacy of rituximab combined with salvage chemotherapy in the second-line
setting has decreased and there is a need for new therapies in patients progressing or
relapsing after first-line rituximab-based therapy. Replacement of rituximab with ofatumumab
in the second-line setting, following progression/relapse after first-line
rituximab-containing regimens, offers the potential to overcome relative or complete
rituximab resistance and thus improve response rates, the ability to proceed to
consolidative HDT/ASCT, and overall survival.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the progression-free survival (PFS) in subjects receiving ofatumumab in addition to salvage chemotherapy (O-chemo) compared to subjects receiving rituximab in addition to salvage chemotherapy (R-chemo)
2 years
No
GSK Clinical Trials
Study Director
GlaxoSmithKline
United States: Institutional Review Board
110928
NCT01014208
March 2010
November 2018
Name | Location |
---|---|
GSK Investigational Site | Raleigh, North Carolina 27609 |
GSK Investigational Site | Park Ridge, Illinois 60068 |
GSK Investigational Site | Pittsburgh, Pennsylvania 15213 |
GSK Investigational Site | Columbia, South Carolina 29210 |
GSK Investigational Site | Germantown, Tennessee 38138 |
GSK Investigational Site | New York, New York 10021 |
GSK Investigational Site | Hartford, Connecticut 06106 |
GSK Investigational Site | Kansas City, Kansas 66160 |
GSK Investigational Site | Hattiesburg, Mississippi 39401 |
GSK Investigational Site | Seattle, Washington 98133 |