Lymphoma, Follicular Clinical Trial
Official title:
Randomized Open Label of Ofatumumab and Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin's Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment
The purpose of this study was to evaluate the safety and efficacy of ofatumumab and bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.
Ofatumumab is an anti-CD20 monoclonal antibody shown to have monotherapy activity in patients
with follicular lymphoma that has relapsed following rituximab-containing therapy.
Bendamustine was approved by FDA for the treatment of in patients with indolent B-cell
Non-Hodgkin's Lymphoma (NHL) that did not respond to rituximab or a rituximab-containing
regimen during or within 6 months of the last rituximab treatment.
Biologics have demonstrated enhanced efficacy when added to chemotherapeutic combinations in
the frontline treatment for indolent NHL. The combination of ofatumumab and bendamustine may
provide additional clinical benefit and efficacy to those who no longer respond to rituximab
or rituximab-containing regimens.
The objective of this study is to determine the effect of ofatumumab and bendamustine
combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or
a rituximab-containing regimen during or within 6 months of the last rituximab treatment.
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