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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
103
Dose of 120 mg/m2 on Day 1 and Day 2 of each treatment cycle (every 21 days). Patients who are continuing to experience clinical benefit at Cycle 6, as assessed by the investigator, may receive up to 2 additional cycles, to a maximum of 8 cycles.
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
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.
Time frame: 6 months
• 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
Time frame: 6 months
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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
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