An Open-Label Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL)
Key
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR), as Determined by the International Working Group (IWG) Criteria As Assessed by Investigators
The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.
up to Week 32
No
Sponsor's Medical Expert
Study Director
Cephalon
United States: Food and Drug Administration
C18083/2048
NCT01108341
May 2010
October 2011
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Texas Oncology, P.A. | Dallas, Texas 75246 |
Columbia Comprehensive Cancer Care Clinic | Columbia, Missouri 65201 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Georgia Cancer Specialists | Decatur, Georgia 30033 |
Hematology Oncology, P.C. | Stamford, Connecticut 06902 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
Oregon Health Sciences University | Portland, Oregon |
Tower Cancer Research Foundation | Beverly Hills, California 90211 |
Mid Dakota Clinic | Bismarck, North Dakota 58501 |
Texas Oncology | Dallas, Texas |
Somerset Hematology Oncology Associates | Somerset, New Jersey 08873 |
The West Clinic | Memphis, Tennessee 38120 |
Kentucky Cancer Clinic | Pikeville, Kentucky 41501 |
Nevada Cancer Institute | Las Vegas, Nevada 89135 |
Longview Cancer Center | Longview, Texas 75601 |
Birmingham Hematology and Oncology Associates, LLC | Birmingham, Alabama 35235 |
Cancer Care Centers of South Texas | San Antonio, Texas 78229 |
Monter Cancer Center | Lake Success, New York 11042 |
Carroll County Cancer Center | Westminster, Maryland 21157 |
Florida Cancer Institute - New Hope | New Port Richey, Florida 34655 |
Northwest Georgia Oncology Center | Marietta, Georgia 30060 |
Cancer Care and Hematology Specialists of Chicagoland | Niles, Illinois 60714 |
Fairfax/Northern Virginia Hematology/Oncology | Fairfax, Virginia 22031 |
University Cancer Institute | Boyton Beach, Florida 33426 |
Dublin Hematology Oncology Care P.C. | Dublin, Georgia 31021 |
Siouxland Hematology-Oncology Assoc. LLP | Sioux City, Iowa 51101 |
University of Pittsburgh Medical Center - Cancer Institute | Pittsburgh, Pennsylvania 15232 |
Joe Arrington Cancer Research | Lubbock, Texas 79410 |
US Oncology Research - Texoma Cancer Center | Wichita Falls, Texas 76310 |
Yakima Valley Memorial Hospital/North Start Lodge | Yakima, Washington 98902 |