The primary objective of the study is to determine the efficacy, as measured by overall response (complete response + partial response) of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-Cell Non-Hodgkin's Lymphoma (NHL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Bendamustine will be administered at 90 mg/m\^2 as a 30-minute intravenous (iv) infusion on days 1 and 2 of each cycle.
Ofatumumab will be administered at 300 mg as an iv infusion on day 1 and 1000 mg on day 8 of cycle 1 and 1000 mg on day 1 of each subsequent cycle.
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR), as Determined by the International Working Group (IWG) Criteria As Assessed by Investigators
The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.
Time frame: up to Week 32
Percentage of Participants With a Best Overall Response of Complete Response (CR), as Determined by the International Working Group (IWG) Criteria As Assessed by Investigators
The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.
Time frame: up to Week 32
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Birmingham Hematology and Oncology Associates, LLC
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Tower Cancer Research Foundation
Beverly Hills, California, United States
Hematology Oncology, P.C.
Stamford, Connecticut, United States
University Cancer Institute
Boynton Beach, Florida, United States
Florida Cancer Institute - New Hope
New Port Richey, Florida, United States
Dublin Hematology Oncology Care P.C.
Dublin, Georgia, United States
Northwest Georgia Oncology Center
Marietta, Georgia, United States
Georgia Cancer Specialists
Tucker, Georgia, United States
Cancer Care and Hematology Specialists of Chicagoland
Niles, Illinois, United States
...and 29 more locations