45
Participants
Start Date
June 30, 2009
Primary Completion Date
December 31, 2011
Study Completion Date
May 31, 2014
Bendamustine
Bendamustine at 90 mg/m\^2 intravenously (iv) on days 1 and 2 of each 28-day cycle. Dosage calculations for bendamustine are based on the patient's body surface area (BSA) at baseline, using actual weight for calculations. If there is a 10% change in a patient's weight during treatment, the most recent weight is used to recalculate the BSA. The new BSA is used in determining the doses to be administered in any subsequent cycles.
Rituximab
Patients receive 375 mg/m\^2 of rituximab, administered by iv infusion on day 1 of every 28-day cycle of treatment. Dosage calculations for rituximab are based on the patient's BSA at baseline, using actual weight for calculations. If there is a 10% change in a patient's weight during treatment, the most recent weight is used to recalculate the BSA. The new BSA is used in determining the doses to be administered in any subsequent cycles.
Teva Investigational Site 11, Fountain Valley
Teva Investigational Site 2, Los Angeles
Teva Investigational Site 35, Orlando
Teva Investigational Site 30, Lafayette
Teva Investigational Site 20, Bethesda
Teva Investigational Site 4, Hackensack
Teva Investigational Site 3, Buffalo
Teva Investigational Site 43, Gettysburg
Teva Investigational Site 33, Bryan
Teva Investigational Site 41, Grapevine
Teva Investigational Site 23, Lynchburg
Teva Investigational Site 6, Ottawa
Teva Investigational Site 7, Toronto
Lead Sponsor
Cephalon
INDUSTRY