Ofatumumab for Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

PHASE2CompletedINTERVENTIONAL
Enrollment

77

Participants

Timeline

Start Date

July 31, 2010

Primary Completion Date

March 31, 2015

Study Completion Date

August 31, 2016

Conditions
Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Interventions
DRUG

Ofatumumab

IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.

Trial Locations (13)

29210

South Carolina Oncology Associates, Columbia

30501

Northeast Georgia Medical Center, Gainesville

32503

Woodlands Medical Specialists, Pensacola

34236

Florida Cancer Specialists, Fort Myers

37203

Tennessee Oncology, Nashville

37404

Chattanooga Oncology Hematology Associates, Chattanooga

43210

The Ohio State University, Columbus

45242

Oncology Hematology Care, Cincinnati

47802

Providence Medical Group, Terre Haute

63017

St. Louis Cancer Care, Chesterfield

91360

Los Robles, Thousand Oaks

03801

Portsmouth Regional Hospital, Portsmouth

07960

Hematology-Oncology Associates of Northern NJ, Morristown

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

SCRI Development Innovations, LLC

OTHER

NCT01113632 - Ofatumumab for Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma | Biotech Hunter | Biotech Hunter