Last updated: 11/04/2018 05:42:39

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

GSK study ID
BEX104526
Clinicaltrials.gov ID
NCT00240591
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

None - Administrative non interventional study to obtain long term safety and efficacy data.

Timeframe: 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.

Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
150
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Other
Clinical publications:
Not applicable
Medical condition
Lymphoma, Non-Hodgkin
Product
tositumomab
Collaborators
Not applicable
Study date(s)
October 2003 to April 2010
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • 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.
  • Inability to meet the above referenced inclusion criteria.
Inclusion and exclusion criteria
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.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2010-19-04

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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