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)

PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

May 31, 2010

Primary Completion Date

July 31, 2011

Study Completion Date

October 31, 2011

Conditions
Non-Hodgkin's Lymphoma (NHL)
Interventions
DRUG

Bendamustine hydrochloride

Bendamustine will be administered at 90 mg/m\^2 as a 30-minute intravenous (iv) infusion on days 1 and 2 of each cycle.

DRUG

Ofatumumab

Ofatumumab will be administered at 300 mg as an iv infusion on day 1 and 1000 mg on day 8 of cycle 1 and 1000 mg on day 1 of each subsequent cycle.

Trial Locations (39)

1000

Cephalon Investigational Site, Brussels

1200

Cephalon Investigational Site, Brussels

11042

Monter Cancer Center, Lake Success

14263

Roswell Park Cancer Institute, Buffalo

15232

University of Pittsburgh Medical Center - Cancer Institute, Pittsburgh

21157

Carroll County Cancer Center, Westminster

22031

Fairfax/Northern Virginia Hematology/Oncology, Fairfax

22100

Cephalon Investigational Site, Nahariya

29605

Cancer Centers of the Carolinas, Greenville

30060

Northwest Georgia Oncology Center, Marietta

30084

Georgia Cancer Specialists, Tucker

31021

Dublin Hematology Oncology Care P.C., Dublin

31096

Cephalon Investigational Site, Haifa

33435

University Cancer Institute, Boynton Beach

34655

Florida Cancer Institute - New Hope, New Port Richey

35235

Birmingham Hematology and Oncology Associates, LLC, Birmingham

38138

The West Clinic, Memphis

41701

Kentucky Cancer Clinic, Hazard

51101

Siouxland Hematology-Oncology Assoc. LLP, Sioux City

58504

Mid Dakota Clinic, Bismarck

60714

Cancer Care and Hematology Specialists of Chicagoland, Niles

65109

Columbia Comprehensive Cancer Care Clinic, Jefferson City

75601

Longview Cancer Center, Longview

76022

Texas Oncology, P.A., Bedford

76310

US Oncology Research - Texoma Cancer Center, Wichita Falls

76712

Texas Oncology, Waco

77598

Texas Oncology, P.A., Webster

78229

Cancer Care Centers of South Texas, San Antonio

78503

Texas Oncology, P.A., McAllen

79410

Joe Arrington Cancer Research, Lubbock

89135

Nevada Cancer Institute, Las Vegas

97239

Oregon Health Sciences University, Portland

98902

Yakima Valley Memorial Hospital/North Start Lodge, Yakima

35294-3300

University of Alabama at Birmingham, Birmingham

90211-1850

Tower Cancer Research Foundation, Beverly Hills

06902

Hematology Oncology, P.C., Stamford

08876

Somerset Hematology Oncology Associates, Somerville

77030-4009

MD Anderson Cancer Center, Houston

Unknown

Cephalon Investigational Site, Ghent

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cephalon

INDUSTRY