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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00240578

Enrollment

Registered

2005-10-18

Start date

2003-11-30

Completion date

2013-06-30

Last updated

2016-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, Non-Hodgkin

Keywords

Long-Term Follow-up, BEXXAR, Iodine I 131 Tositumomab, Low-grade lymphoma

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
long term followup data	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.

Outcome results