Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab
- Registration Number
- NCT00139841
- Lead Sponsor
- Cephalon
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Bendamustine HCl bendamustine
- Primary Outcome Measures
Name Time Method Assess the overall response rate (ORR = CR + CRu + PR) and duration of response (DR) to a regimen of bendamustine in patients who are refractory to rituximab therapy. 6 months
- Secondary Outcome Measures
Name Time Method • assess the safety profile of Treanda in this patient population. • assess the duration of progression-free survival (PFS). • estimate the basic pharmacokinetic parameters • assess the effects of plasma concentrations 6 months
Trial Locations
- Locations (40)
USC/Norris Cancer Hospital
🇺🇸Los Angeles, California, United States
LSU Health Sciences Center, Feist Weiller Cancer Center
🇺🇸Shreveport, Louisiana, United States
Markey Cancer Center, University of Kentucky Medical Center
🇺🇸Lexington, Kentucky, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Alta Bates Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Tower Hematology and Oncology Medical Group
🇺🇸Beverly Hills, California, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Stanford University Division of Oncology
🇺🇸Stanford, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Indiana Oncology Hematology Consultants, A Division of AHN
🇺🇸Indianapolis, Indiana, United States
University of Michigan Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Washington University School of Medicine in St. Louis
🇺🇸St. Louis, Missouri, United States
University of Rochester Medical Center, James P. Wilmot Cancer Center
🇺🇸Rochester, New York, United States
Weill Cornell Cancer Care Center
🇺🇸New York, New York, United States
University of New Mexico Cancer Research and Treatment Center
🇺🇸Albuquerque, New Mexico, United States
Interlakes Foundation, Inc.
🇺🇸Rochester, New York, United States
The Cleveland Clinic Foundation Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Duke University School of Medicine
🇺🇸Durham, North Carolina, United States
Arlington Cancer Center
🇺🇸Arlington, Texas, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
British Columbia Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
Ottawa Hospital - General Campus
🇨🇦Ottawa, Ontario, Canada
Hopital Notre-Dame du CHUM
🇨🇦Montreal, Quebec, Canada
Queen Elizabeth Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
Saskatchewan Cancer Center Agency
🇨🇦Saskatoon, Saskatchewan, Canada
Hopital du Sacre Couer de Montreal
🇨🇦Montreal, Quebec, Canada
Comprehensive Cancer Center - Desert Regional Medical Center
🇺🇸Palm Springs, California, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
The West Clinic/ACORN
🇺🇸Memphis, Tennessee, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Hospital Espanol Auxilio Mutuo, Auxilio Mutuo Cancer Center
🇵🇷San Juan, Puerto Rico
Nevada Cancer Institute
🇺🇸Las Vegas, Nevada, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States