Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab
Completed · Phase 3
Conditions studied: Non-Hodgkin's Lymphoma
In brief
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.
Key facts
- Study ID
- NCT00139841
- Run by
- Cephalon
- People needed
- 103
- Starts
- 2005-10-01
- Expected to finish
- 2009-10-01
- Last updated by the study team
- 2014-05-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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 D.C., 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
Full record on ClinicalTrials.gov
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