drugset / Trial / NCT01868035

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

NCT01868035

Phase 2 Completed 15 enrolled GlaxoSmithKline
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2000-05
Primary completion
2012-10
Completion
2012-10

Drugs

EvaluationDrugModalityDoseRoute
Subject TOSITUMOMAB 131I Monoclonal antibody 35 mg Intravenous
Subject TOSITUMOMAB 131I Monoclonal antibody 185 mbq Intravenous
Subject Tositumomab Monoclonal antibody 450 mg Intravenous

Indications