15
Participants
Start Date
May 31, 2000
Primary Completion Date
October 31, 2012
Study Completion Date
October 31, 2012
tositumomab and iodine I-131 tositumomab
"Subjects received the following treatments of TST/I-131 TST by intravenous (IV) infusion:~Dosimetric Dose: 450 mg of TST infused over 1 hour immediately followed by 35 mg of TST labeled with 5 milliCuries (mCi) of I 131 infused over 30 minutes.~Therapeutic Dose: 7 to 14 days after the dosimetric dose, 450 mg of TST infused over 60 minutes, immediately followed by 35 mg of TST labeled with the subject-specific mCi activity of I 131 needed to deliver a total body dose of 75 centiGrays (cGy), infused over 30 minutes for subjects with a platelet count of 150,000/mm3. Subjects with platelet counts of 100,000 to 149,999/mm3 received 65 cGy, and obese subjects were dosed based upon 137% of their calculated lean body mass."
Lead Sponsor
GlaxoSmithKline
INDUSTRY