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

Primary Purpose

Lymphoma, Non-Hodgkin

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Lymphoma, Non-Hodgkin focused on measuring BEXXAR, Tositumomab, Iodine I 131 Tositumomab, low-grade follicular lymphomas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must have enrolled in one of the following Corixa sponsored clinical trials: RIT-I-000, RIT-II-001, RIT-II-002, RIT II-004 or CP-97-012 and are >2 years post Tositumomab and/or Iodine I 131 Tositumomab administration. 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 the above referenced inclusion criteria.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    None - Administrative non interventional study to obtain long term safety and efficacy data.
    Study BEX104526 (formerly Corixa Study CCBX001-051) was designed to obtain long-term safety and efficacy data from the surviving subjects who completed at least 2 years of follow-up following administration of TST/I-131 TST while on Study BEX104728 (RIT-I-000), BEX104731 (RIT-II-001), BEX104504 (RIT-II-004), BEX104515 (RIT-II-002), or BEX104507 (CP-97-012). Analyses will be performed according to one of the five primary interventional protocols.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 14, 2005
    Last Updated
    November 9, 2015
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00240591
    Brief Title
    Patients With Low-Grade Non-Hodgkin's Lymphoma Previously Treated With Tositumomab and/or Iodine I 131 Tositumomab
    Official Title
    A MULTI-CENTER LONG-TERM FOLLOW-UP STUDY OF PATIENTS WITH LOW-GRADE NON-HODGKIN'S LYMPHOMA PREVIOUSLY TREATED WITH TOSITUMOMAB AND/OR IODINE I 131 TOSITUMOMAB IN STUDIES RIT-I-000, RIT-II-001, RIT-II-002, RIT-II-004, or CP-97-012
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2003 (undefined)
    Primary Completion Date
    June 2010 (Actual)
    Study Completion Date
    June 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GlaxoSmithKline

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a study for the long-term follow-up of patients who completed at least two years of follow-up after treatment with Tositumomab and/or Iodine I 131 Tositumomab (BEXXAR)on Study RIT-I-000, RIT-II-001, RIT-II-002, RIT-II-004 or CP-97-012. All patients will be assessed for survival and disease status, including subsequent therapy for NHL, and for long term safety. Laboratory evaluations consisting of a TSH level (for all patients) and a complete blood cell (CBC) count with a differential and platelet count (for patients in continuing response only) will be obtained annually through Year 10 post treatment with Tositumomab and/or Iodine I 131 Tositumomab. Patients that remain in response to their previous treatment with BEXXAR, will additionally be followed radiographically for response and progression.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphoma, Non-Hodgkin
    Keywords
    BEXXAR, Tositumomab, Iodine I 131 Tositumomab, low-grade follicular lymphomas

    7. Study Design

    Enrollment
    150 (Actual)
    Primary Outcome Measure Information:
    Title
    None - Administrative non interventional study to obtain long term safety and efficacy data.
    Description
    Study BEX104526 (formerly Corixa Study CCBX001-051) was designed to obtain long-term safety and efficacy data from the surviving subjects who completed at least 2 years of follow-up following administration of TST/I-131 TST while on Study BEX104728 (RIT-I-000), BEX104731 (RIT-II-001), BEX104504 (RIT-II-004), BEX104515 (RIT-II-002), or BEX104507 (CP-97-012). Analyses will be performed according to one of the five primary interventional protocols.
    Time Frame
    Subjects enrolled in Study BEX104526 were followed for continued response (as applicable) and safety every 6 months for Years 3 through 5 post-treatment with TST/I-131 TST. Beginning at Year 6, subjects were assessed annually through Year 10 inclusive.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must have enrolled in one of the following Corixa sponsored clinical trials: RIT-I-000, RIT-II-001, RIT-II-002, RIT II-004 or CP-97-012 and are >2 years post Tositumomab and/or Iodine I 131 Tositumomab administration. 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 the above referenced inclusion criteria.
    Study Population Description
    The study population consists of patients with NHL previously treated at least 2 years ago with Tositumomab and/or Iodine I 131 Tositumomab on Study RIT-I-000, RIT-II-001, RIT-II-002, RIT-II-004, or CP-97-012.
    Sampling Method
    Non-Probability Sample
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials
    Organizational Affiliation
    GlaxoSmithKline
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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