NCT00240591

Patients With Low-Grade Non-Hodgkin's Lymphoma Previously Treated With Tositumomab and/or Iodine I 131 Tositumomab

A MULTI-CENTER LONG-TERM FOLLOW-UP STUDY OF PATIENTS WITH LOW-GRADE NON-HODGKIN'S LYMPHOMA PREVIOUSLY TREATED WITH TOSITUMOMAB AND/OR IODINE I 131 TOSITUMOMAB IN STUDIES RIT-I-000, RIT-II-001, RIT-II-002, RIT-II-004, or CP-97-012

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study for the long-term follow-up of patients who completed at least two years of follow-up after treatment with Tositumomab and/or Iodine I 131 Tositumomab (BEXXAR)on Study RIT-I-000, RIT-II-001, RIT-II-002, RIT-II-004 or CP-97-012. All patients will be assessed for survival and disease status, including subsequent therapy for NHL, and for long term safety. Laboratory evaluations consisting of a TSH level (for all patients) and a complete blood cell (CBC) count with a differential and platelet count (for patients in continuing response only) will be obtained annually through Year 10 post treatment with Tositumomab and/or Iodine I 131 Tositumomab. Patients that remain in response to their previous treatment with BEXXAR, will additionally be followed radiographically for response and progression.

Conditions

• Lymphoma, Non-Hodgkin

Timeline

• Start date: 2003-10-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2005-10-18
• Last updated: 2015-11-11