Patients With Low-Grade Non-Hodgkin's Lymphoma Previously Treated With Tositumomab and/or Iodine I 131 Tositumomab
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|ClinicalTrials.gov Identifier: NCT00240591|
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : November 11, 2015
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||150 participants|
|Official Title:||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|
|Study Start Date :||October 2003|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
- None - Administrative non interventional study to obtain long term safety and efficacy data. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240591
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|