NCT00240578

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2003

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

February 1, 2016

Status Verified

January 1, 2016

Enrollment Period

9.6 years

First QC Date

October 14, 2005

Last Update Submit

January 28, 2016

Conditions

Lymphoma, Non-Hodgkin

Keywords

Long-Term Follow-upBEXXARIodine I 131 TositumomabLow-grade lymphoma

Outcome Measures

Primary Outcomes (1)

  • long term followup data

    safety and efficacy data will be presented as follow up data with updates to studies 104505, 393229/023, 393229/007, 104514 and 393229/028.

    every 3 months at Months 6, 9, 12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of subjects which have been previously treated with Iodine I 131 Tositumomab in Studies 104505, 93229/023, 393229/007, 104514 and 393229/028.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2005

First Posted

October 18, 2005

Study Start

November 1, 2003

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

February 1, 2016

Record last verified: 2016-01