Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab
NCT ID: NCT00139841
Last Updated: 2014-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
103 participants
INTERVENTIONAL
2005-10-31
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
bendamustine
Bendamustine HCl
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.
Interventions
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Bendamustine HCl
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
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Inclusion Criteria
* 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
Exclusion Criteria
* History of prior high dose chemotherapy with allogeneic stem cell support (history of autologous stem cell support is permissible)
18 Years
ALL
No
Sponsors
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Cephalon
INDUSTRY
Responsible Party
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Locations
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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
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
Countries
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Other Identifiers
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SDX-105-03
Identifier Type: -
Identifier Source: org_study_id
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