Iodine-131 Anti-B1 Antibody Consolidation for Patients With Non-Hodgkin's Lymphoma Following First-line CHOP

PHASE2CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

May 31, 2000

Primary Completion Date

October 31, 2012

Study Completion Date

October 31, 2012

Conditions
Lymphoma, Non-Hodgkin
Interventions
DRUG

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."

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY