At a glance
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Phase II Multicenter Study of Iodine-131 Anti-B1 Antibody Consolidation For Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma Following First-line CHOP
In Brief
A Phase 2 clinical trial evaluating tositumomab and iodine I-131 tositumomab for Lymphoma, Non-Hodgkin. Completed, enrolled 15 participants.
Detailed Summary
This is a multicenter study for the long-term follow-up of surviving patients who are expected to complete or who have completed at least two years of follow-up after treatment with Iodine I 131 Tositumomab (BEXXAR) on studies CP-97-011, CP-98-025, CP-99-032, or CP-99-036. All patients will be assessed for survival and disease status, including subsequent therapy for Diffuse Large B-cell Non-Hodgkin's Lymphoma (NHL), and for long-term safety. Additionally laboratory evaluations consisting of a thyroid stimulating hormone (TSH) level and a complete blood cell (CBC) count with a differential and platelet count will be obtained annually. Additionally, patients who remain in long-term response following Iodine I 131 Tositumomab treatment will be followed for response and progression.
Study Details
Timeline
Interventions
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.