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Rituximab and Chemotherapy Followed by Ibritumomab Tiuxetan as Treatment for Low Grade Follicular Non-Hodgkin's Lymphoma

Primary Purpose

Non-Hodgkins Lymphoma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Rituximab
CHOP
CVP
Ibritumomab Tiuxetan
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkins Lymphoma

Eligibility Criteria

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

Inclusion Criteria: To be included in this study, you must meet the following criteria: Histologic documentation of follicular center, B-cell lymphoma Early stage lymphoma (stages I or II) relapsed after radiation therapy alone No previous chemotherapy or monoclonal antibody therapy Measurable or evaluable disease Able to perform activities of daily living with minimal assistance Age > 18 years Adequate bone marrow ,liver and kidney function Must be accessible for treatment and follow-up. Bone marrow examination initial staging and accurate restaging All patients must give written informed consent prior to study entry. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Small lymphocytic (CLL type) lymphomas and CLL Impaired bone marrow reserve Female pregnant or lactating Serious active infection at the time of treatment Any other serious underlying condition Central nervous system involvement (brain or meningeal) HIV or AIDS-related lymphoma Received prior external beam radiation therapy to > 25% of active bone marrow Pleural effusion Received prior murine antibodies or proteins History of other neoplasms within five years of diagnosis Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Overall clinical response rate
    Overall molecular response rate

    Secondary Outcome Measures

    Progression-free survival
    Overall survival
    Overall toxicity

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    December 29, 2010
    Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Biogen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00193440
    Brief Title
    Rituximab and Chemotherapy Followed by Ibritumomab Tiuxetan as Treatment for Low Grade Follicular Non-Hodgkin's Lymphoma
    Official Title
    Phase II Trial of Rituximab and Short Duration Chemotherapy Followed by Zevalin as First-Line Treatment for Patients With Low Grade Follicular Non-Hodgkin's Lymphoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2002 (undefined)
    Primary Completion Date
    April 2004 (Actual)
    Study Completion Date
    January 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Biogen

    4. Oversight

    5. Study Description

    Brief Summary
    In this trial, we will evaluate the feasibility, toxicity, and effectiveness ibritumomab tiuxetan, when incorporated into combination first-line treatment for follicular lymphoma. Addition of the ibritumomab tiuxetan to our previously evaluated, well tolerated combination of rituximab and short course chemotherapy will allow the use of additional active agent with a unique mechanism of cytotoxicity. In addition, "debulking" of lymphoma prior to 90Y Zevalin administration may minimize the myelotoxicity of this agent.
    Detailed Description
    Upon determination of eligibility, patients will be receive: Rituxan + CHOP or CVP + Ibritumomab Tiuxetan Patients who are considered medical candidates for doxorubicin should receive CHOP chemotherapy (Cyclophosphamide, doxorubicin, vincristine and prednisone). Patients who are not considered medical candidates for doxorubicin should receive CVP chemotherapy (Cyclophosphamide, Vincristine, and prednisone)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Hodgkins Lymphoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Rituximab
    Intervention Type
    Drug
    Intervention Name(s)
    CHOP
    Intervention Type
    Drug
    Intervention Name(s)
    CVP
    Intervention Type
    Drug
    Intervention Name(s)
    Ibritumomab Tiuxetan
    Primary Outcome Measure Information:
    Title
    Overall clinical response rate
    Title
    Overall molecular response rate
    Secondary Outcome Measure Information:
    Title
    Progression-free survival
    Title
    Overall survival
    Title
    Overall toxicity

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: To be included in this study, you must meet the following criteria: Histologic documentation of follicular center, B-cell lymphoma Early stage lymphoma (stages I or II) relapsed after radiation therapy alone No previous chemotherapy or monoclonal antibody therapy Measurable or evaluable disease Able to perform activities of daily living with minimal assistance Age > 18 years Adequate bone marrow ,liver and kidney function Must be accessible for treatment and follow-up. Bone marrow examination initial staging and accurate restaging All patients must give written informed consent prior to study entry. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Small lymphocytic (CLL type) lymphomas and CLL Impaired bone marrow reserve Female pregnant or lactating Serious active infection at the time of treatment Any other serious underlying condition Central nervous system involvement (brain or meningeal) HIV or AIDS-related lymphoma Received prior external beam radiation therapy to > 25% of active bone marrow Pleural effusion Received prior murine antibodies or proteins History of other neoplasms within five years of diagnosis Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John D. Hainsworth, MD
    Organizational Affiliation
    SCRI Development Innovations, LLC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19525191
    Citation
    Hainsworth JD, Spigel DR, Markus TM, Shipley D, Thompson D, Rotman R, Dannaher C, Greco FA. Rituximab plus short-duration chemotherapy followed by Yttrium-90 Ibritumomab tiuxetan as first-line treatment for patients with follicular non-Hodgkin lymphoma: a phase II trial of the Sarah Cannon Oncology Research Consortium. Clin Lymphoma Myeloma. 2009 Jun;9(3):223-8. doi: 10.3816/CLM.2009.n.044.
    Results Reference
    result

    Learn more about this trial

    Rituximab and Chemotherapy Followed by Ibritumomab Tiuxetan as Treatment for Low Grade Follicular Non-Hodgkin's Lymphoma

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