A Randomized, Open Label Study of Ofatumumab and Bendamustine Combination Therapy 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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free-survival following ofatumumab and bendamustine combination therapy
GSK Clinical Trials
United States: Institutional Review Board
|GSK Investigational Site||Phoenix, Arizona 85013 - 4496|
|GSK Investigational Site||Savannah, Georgia 31405|
|GSK Investigational Site||Baltimore, Maryland 21201|
|GSK Investigational Site||Royal Oak, Michigan 48073|
|GSK Investigational Site||Pittsburgh, Pennsylvania 15213|
|GSK Investigational Site||Germantown, Tennessee 38138|
|GSK Investigational Site||New York, New York 10021|
|GSK Investigational Site||Washington, District of Columbia 20307-5001|
|GSK Investigational Site||Coeur d'Alene, Idaho 83814|
|GSK Investigational Site||Seattle, Washington 98133|
|GSK Investigational Site||Morgantown, West Virginia 26506|