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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lymphoma, Non-Hodgkin
- Sponsor
- GlaxoSmithKline
- Enrollment
- 88
- Primary Endpoint
- long term followup data
- Status
- Completed
- Last Updated
- 10 years ago
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.
Investigators
Eligibility Criteria
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.