A MULTI-CENTER LONG-TERM FOLLOW-UP STUDY OF PATIENTS WITH LOW-GRADE NON-HODGKIN'S LYMPHOMA PREVIOUSLY TREATED WITH IODINE I 131 TOSITUMOMAB IN STUDIES CP-97-011, CP-98-025, CP-99-032, or CP-99-036
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 88
- Primary Endpoint
- long term followup data
Study Overview
Brief Summary
This is a multi-center study for the long-term follow-up of surviving patients who are expected to complete or who have completed at least two years of follow-up after treatment with Iodine I 131 Tositumomab (BEXXAR) on Studies CP-97-011, CP-98-025, CP-99-032, or CP-99-036. All patients will be assessed for survival and disease status, including subsequent therapy for NHL, and for long-term safety. Additionally Laboratory evaluations consisting of a TSH level and a complete blood cell (CBC) count with a differential and platelet count will be obtained annually. Additionally, patients who remain in long-term response following Iodine I 131 Tositumomab treatment will be followed for response and progression.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients must have enrolled in one of the following Corixa sponsored clinical trials: CP-97-011, CP-98-025, CP-99-032, or CP-99-036 and are >2 years post treatment with Iodine I 131 Tositumomab.
- •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 above referenced inclusion criteria.
Outcomes
Primary Outcomes
long term followup data
Time Frame: every 3 months at Months 6, 9, 12
safety and efficacy data will be presented as follow up data with updates to studies 104505, 393229/023, 393229/007, 104514 and 393229/028.
Secondary Outcomes
No secondary outcomes reported