This is a multi-center, randomized, study to compare Iodine I 131 Tositumomab therapeutic regimen to Ibritumomab Tiuxetan therapeutic regimen in the treatment of patients with relapsed or transformed follicular non-Hodgkin's B-cell lymphoma. A total of 350 patients, approximately 175 patients per arm, will be enrolled at 30 to 40 sites in the United States.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
GSK Clinical Trials Call Center
Iowa City, Iowa, United States
GSK Clinical Trial Call Center
St Louis, Missouri, United States
GSK Clinical Trials Call Center
Buffalo, New York, United States
GSK Clinical Trials Call Center
Charleston, North Carolina, United States
The primary endpoint is the proportion of subjects experiencing Grade 3/4 hematological toxicity within 120 days from completion of treatment regimen administration.
The final analysis will be carried out when 130 events (progressive disease, death or subsequent therapy) have occurred in the control arm, expected approximately 18 months after last subject last visit.
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GSK Clinical Trial Call Center
Portland, Oregon, United States
GSK Clinical Trial Call Center
Knoxville, Tennessee, United States
GSK Clinical Trial Call Center
Seattle, Washington, United States
GSK Clinical Trials Call Center
Tacoma, Washington, United States