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

Lymphoma, Non-Hodgkin Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00240591
• Other study ID #: BEX104526
• Status: Completed
• Phase: N/A
• First received: October 14, 2005
• Last updated: November 9, 2015
• Start date: October 2003
• Est. completion date: June 2010

Study information

• Verified date: November 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

N/A

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	None - Administrative non interventional study to obtain long term safety and efficacy data.	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.	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.	No