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

Completed

• Conditions: Lymphoma, Non-Hodgkin

• Registration Number: NCT00240591
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2005-10-14
• Study First Submitted QC: 2005-10-14
• Study First Posted: 2005-10-18
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-09
• Last Update Posted: 2015-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients must have enrolled in one of the following Corixa sponsored clinical trials: RIT-I-000, RIT-II-001, RIT-II-002, RIT II-004 or CP-97-012 and are >2 years post Tositumomab and/or Iodine I 131 Tositumomab administration.
• Patients must give written informed consent by signing an IRB/ethics committee approved consent form prior to entry on this follow-up study.

Exclusion Criteria

• Inability to meet the above referenced inclusion criteria.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
None - Administrative non interventional study to obtain long term safety and efficacy data.	Subjects enrolled in Study BEX104526 were followed for continued response (as applicable) and safety every 6 months for Years 3 through 5 post-treatment with TST/I-131 TST. Beginning at Year 6, subjects were assessed annually through Year 10 inclusive.	Study BEX104526 (formerly Corixa Study CCBX001-051) was designed to obtain long-term safety and efficacy data from the surviving subjects who completed at least 2 years of follow-up following administration of TST/I-131 TST while on Study BEX104728 (RIT-I-000), BEX104731 (RIT-II-001), BEX104504 (RIT-II-004), BEX104515 (RIT-II-002), or BEX104507 (CP-97-012). Analyses will be performed according to one of the five primary interventional protocols.