Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab
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
1 other identifier
interventional
103
3 countries
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2005
Typical duration for phase_3
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2005
CompletedFirst Posted
Study publicly available on registry
August 31, 2005
CompletedStudy Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedMay 9, 2014
May 1, 2014
1.7 years
August 18, 2005
May 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
• 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
Study Arms (1)
1
EXPERIMENTALbendamustine
Interventions
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.
Eligibility Criteria
You may qualify if:
- Documented B-cell Non-Hodgkin's Lymphoma
- Small lymphocytic lymphoma (ALC \< 5,000 cells/mm3)
- Marginal zone B-cell lymphoma (nodal, extranodal, or splenic types)
- Lymphoplasmacytic lymphoma
- Follicular center lymphoma, follicular
- Disease documented to be refractory to a full-course of the most recent rituximab therapy (single agent or combination)
- At least 1 prior chemotherapy regimen and maximum of 3 prior chemotherapy regimens
- Bidimensionally measurable disease (by CT scan) with at least one lesion measuring ≥ 2.0 cm in a single dimension
You may not qualify if:
- Patients who receive rituximab only as part of treatment with ibritumomab tiuxetan (Zevalin®) will not be eligible
- History of prior high dose chemotherapy with allogeneic stem cell support (history of autologous stem cell support is permissible)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cephalonlead
Study Sites (40)
University of Alabama Birmingham
Birmingham, Alabama, 35233, United States
Arizona Cancer Center
Tucson, Arizona, 85724, United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704, United States
Tower Hematology and Oncology Medical Group
Beverly Hills, California, 90211, United States
Moores UCSD Cancer Center
La Jolla, California, 92093, United States
USC/Norris Cancer Hospital
Los Angeles, California, 90033, United States
Comprehensive Cancer Center - Desert Regional Medical Center
Palm Springs, California, 92662, United States
Stanford University Division of Oncology
Stanford, California, 94305, United States
University of Colorado Cancer Center
Aurora, Colorado, 80010, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Indiana Oncology Hematology Consultants, A Division of AHN
Indianapolis, Indiana, 46202, United States
Markey Cancer Center, University of Kentucky Medical Center
Lexington, Kentucky, 40536, United States
LSU Health Sciences Center, Feist Weiller Cancer Center
Shreveport, Louisiana, 71130, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110, United States
Nevada Cancer Institute
Las Vegas, Nevada, 89135, United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, 87131, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Weill Cornell Cancer Care Center
New York, New York, 10021, United States
Interlakes Foundation, Inc.
Rochester, New York, 14623, United States
University of Rochester Medical Center, James P. Wilmot Cancer Center
Rochester, New York, 14642, United States
Duke University School of Medicine
Durham, North Carolina, 27710, United States
The Cleveland Clinic Foundation Taussig Cancer Center
Cleveland, Ohio, 44195, United States
The West Clinic/ACORN
Memphis, Tennessee, 38138, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Arlington Cancer Center
Arlington, Texas, 76012, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6, Canada
Queen Elizabeth Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Ottawa Hospital - General Campus
Ottawa, Ontario, KIH8L6, Canada
Hopital Notre-Dame du CHUM
Montreal, Quebec, H2: 4M1, Canada
Hopital du Sacre Couer de Montreal
Montreal, Quebec, H4J 1C5, Canada
Saskatchewan Cancer Center Agency
Saskatoon, Saskatchewan, S7N 4H4, Canada
Hospital Espanol Auxilio Mutuo, Auxilio Mutuo Cancer Center
San Juan, 00919, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2005
First Posted
August 31, 2005
Study Start
October 1, 2005
Primary Completion
July 1, 2007
Study Completion
October 1, 2009
Last Updated
May 9, 2014
Record last verified: 2014-05