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Brief Title: Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab
Official Title: A Multi-Center Phase III Study to Investigate the Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab
Study ID: NCT00139841
Brief Summary: SUMMARY: This is a multi-center open label study to evaluate the safety and effectiveness of Treanda™ (also known as bendamustine HCl or SDX-105) in patients who have indolent Non-Hodgkin's lymphoma and have relapsed within a defined timeframe after taking rituximab (Rituxan®). Treanda will be given via 60-minute intravenous infusion on days 1 and 2 of every 21-day treatment cycle. Patients will be treated for 6 cycles unless they develop progressive disease or unacceptable toxicity. Those who continue to receive clinical benefit at end of 6 cycles may receive an additional 2 cycles. Following the end of treatment, patients will be followed for up to 2 years until disease progression or start of another anti-cancer therapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama Birmingham, Birmingham, Alabama, United States
Arizona Cancer Center, Tucson, Arizona, United States
Alta Bates Comprehensive Cancer Center, Berkeley, California, United States
Tower Hematology and Oncology Medical Group, Beverly Hills, California, United States
Moores UCSD Cancer Center, La Jolla, California, United States
USC/Norris Cancer Hospital, Los Angeles, California, United States
Comprehensive Cancer Center - Desert Regional Medical Center, Palm Springs, California, United States
Stanford University Division of Oncology, Stanford, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Yale University School of Medicine, New Haven, Connecticut, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
Rush University Medical Center, Chicago, Illinois, United States
Indiana Oncology Hematology Consultants, A Division of AHN, Indianapolis, Indiana, United States
Markey Cancer Center, University of Kentucky Medical Center, Lexington, Kentucky, United States
LSU Health Sciences Center, Feist Weiller Cancer Center, Shreveport, Louisiana, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan Cancer Center, Ann Arbor, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
Washington University School of Medicine in St. Louis, St. Louis, Missouri, United States
Nevada Cancer Institute, Las Vegas, Nevada, United States
University of New Mexico Cancer Research and Treatment Center, Albuquerque, New Mexico, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Weill Cornell Cancer Care Center, New York, New York, United States
Interlakes Foundation, Inc., Rochester, New York, United States
University of Rochester Medical Center, James P. Wilmot Cancer Center, Rochester, New York, United States
Duke University School of Medicine, Durham, North Carolina, United States
The Cleveland Clinic Foundation Taussig Cancer Center, Cleveland, Ohio, United States
The West Clinic/ACORN, Memphis, Tennessee, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Arlington Cancer Center, Arlington, Texas, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
University of Wisconsin, Madison, Wisconsin, United States
Cross Cancer Institute, Edmonton, Alberta, Canada
British Columbia Cancer Agency, Vancouver, British Columbia, Canada
Queen Elizabeth Health Sciences Centre, Halifax, Nova Scotia, Canada
Ottawa Hospital - General Campus, Ottawa, Ontario, Canada
Hopital Notre-Dame du CHUM, Montreal, Quebec, Canada
Hopital du Sacre Couer de Montreal, Montreal, Quebec, Canada
Saskatchewan Cancer Center Agency, Saskatoon, Saskatchewan, Canada
Hospital Espanol Auxilio Mutuo, Auxilio Mutuo Cancer Center, San Juan, , Puerto Rico