Rapid Infusion of Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

July 31, 2013

Primary Completion Date

December 31, 2015

Study Completion Date

March 31, 2017

Conditions
Chronic Lymphocytic Leukemia
Interventions
DRUG

Ofatumumab

The first dose of ofatumumab administered on Day 1 will be 300 mg to minimize infusion reactions. If the initial 300 mg dose of ofatumumab is well-tolerated, without occurrence of any infusion-associated AEs of \>= grade 3, on Day 3 ofatumumab will increase to 1000 mg IV. If the Day 3 dose was well-tolerated (i.e., no infusion-associated AE \>= grade 3), on Day 8 the ofatumumab dose will escalate to 2000 mg IV. To achieve the primary endpoint for this study, 20% of the 2000 mg ofatumumab dose only will be administered over the first 30 minutes and if tolerated the remaining 80% of the dose will be infused over the remaining 1.5/hours of each treatment. Ofatumumab doses, weeks 3-8, will remain at 2000 mg IV with no further dose escalations. If the Day 8 (Week 2) dose is tolerated all subsequent doses may be infused in the same manner.

Trial Locations (6)

33705

Florida Cancer Specialists-North, St. Petersburg

33916

Florida Cancer Specialists-South, Fort Myers

37203

Tennessee Oncology PLLC, Nashville

37404

Chattanooga Oncology Hematology Associates, Chattanooga

45242

Oncology Hematology Associates, Cincinnati

80218

Colorado Blood Cancer Institute, Denver

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

collaborator

Novartis

INDUSTRY

lead

SCRI Development Innovations, LLC

OTHER