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Spots Global Cancer Trial Database for Rapid Infusion of Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

Official Title: Rapid Infusion of Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia, a Phase II Trial

Study ID: NCT01848145

Interventions

Ofatumumab

Study Description

Brief Summary: This is a Phase II, single-arm study of ofatumumab investigating the safety of an accelerated infusion schedule of ofatumumab in patients who have received at least one prior therapy for CLL. The primary endpoint is to evaluate the number of subjects able to complete infusion number 3 (2000 mg) within 15 minutes of the planned time.

Detailed Description: The purpose of this study is to develop an accelerated infusion regimen that allows ofatumumab to be delivered in a safe manner while minimizing the time required administering the treatment. We hypothesize there will be fewer infusion-related reactions using the proposed dose-dense approach the first week before accelerating the rate of infusion.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Colorado Blood Cancer Institute, Denver, Colorado, United States

Florida Cancer Specialists-South, Fort Myers, Florida, United States

Florida Cancer Specialists-North, Saint Petersburg, Florida, United States

Oncology Hematology Associates, Cincinnati, Ohio, United States

Chattanooga Oncology Hematology Associates, Chattanooga, Tennessee, United States

Tennessee Oncology PLLC, Nashville, Tennessee, United States

Contact Details

Name: Ian Flinn, MD, PhD

Affiliation: SCRI Development Innovations, LLC

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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