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

NCT ID: NCT00240578

Last Updated: 2016-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-11-30

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphoma, Non-Hodgkin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

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BEX104528

Identifier Type: -

Identifier Source: org_study_id

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