Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant (ASCT) in Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant (ASCT) in Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
This study is being conducted to compare the efficacy and safety of ofatumumab in addition to salvage chemotherapy versus rituximab in addition to salvage chemotherapy in CD20 positive DLBCL subjects relapsing, or with persistent disease, after first-line treatment with rituximab combined with an anthracycline-based chemotherapy regimen and be eligible for ASCT.
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.
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Exclusion Criteria:
Chaple Hill, North Carolina 27599-7305, United States
Capital Federal, Buenos Aires C1426ANZ, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1431FWO, Argentina
Jianan, Shandong 250012, China
Jiang Su Province, 215006, China
James Street, 8, Ireland
Hokkaido, 060-8648, Japan
Sittard-geleen, 6162 BG, Netherlands
Jellanamdo, 519-809, South Korea
Pozuelo de Alarcón/Madrid, 28223, Spain
Headington, Oxford, OX3 7LE, United Kingdom
Whitchurch, Cardiff, CF14 2TL, United Kingdom