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A Study of Galiximab + Rituximab Versus Rituximab + Placebo in Follicular Non-Hodgkin's Lymphoma (NHL)

Primary Purpose

Lymphoma, Non-Hodgkin's

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Galiximab in combination with rituximab
Rituximab in combination with placebo
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin's focused on measuring relapsed, NHL, pharmacokinetics, antibody, safety, galiximab, efficacy, rituximab, refractory

Eligibility Criteria

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

Key Inclusion Criteria: Key Inclusion Criteria: Aged >= 18 years old at the time of informed consent. Histologically confirmed follicular Grade 1-3a NHL. Relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment. Bidimensionally measurable disease with at least 1 lesion >= 2.0 cm in a single dimension. Acceptable hematologic, hepatic, and renal function parameters. Recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, autologous bone marrow or stem cell transplant, or investigational drugs. Key Exclusion Criteria: Follicular lymphoma Grade 3b. Rituximab refractory or refractory to anti-CD20 radioimmunotherapy (no response to prior rituximab or prior rituximab-containing regimen, or a response with a TTP of less than 6 months). Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to Study Day 1 (6 weeks if nitrosourea or mitomycin C). Prior lymphoma vaccine therapy within 12 months prior to Study Day 1. Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to Study Day 1. Autologous bone marrow or stem cell transplant within 6 months prior to Study Day 1. Prior allogeneic transplant. Transfusion-dependent subjects. Another primary malignancy requiring active treatment (except hormonal therapy). Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions, which would compromise protocol objectives in the opinion of the Investigator and/or the Sponsor. New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to Study Day 1.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Outcomes

    Primary Outcome Measures

    To assess efficacy as measured by progression free survival (PFS), and determine whether rituximab plus galiximab compared to rituximab plus placebo may extend PFS.

    Secondary Outcome Measures

    Secondary efficacy measures include: event-free survival, time to progression, duration of response, complete response rate, and overall survival.
    Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodies.
    Pharmacokinetics
    Quality of Life using both the Functional Assessment of Cancer Therapy-Lymphoma (FACT-lym) and the EQ-5D (EuroQoL) instruments

    Full Information

    First Posted
    August 11, 2006
    Last Updated
    September 17, 2015
    Sponsor
    Biogen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00363636
    Brief Title
    A Study of Galiximab + Rituximab Versus Rituximab + Placebo in Follicular Non-Hodgkin's Lymphoma (NHL)
    Official Title
    A Phase III, Randomized, Double-Blind Study of Galiximab in Combination With Rituximab Compared With Rituximab in Combination With Placebo for the Treatment of Subjects With Relapsed or Refractory, Follicular Non-Hodgkin's Lymphoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2011
    Overall Recruitment Status
    Terminated
    Why Stopped
    Enrollment challenges due to changes in standards of care resulted in premature termination. No safety or efficacy events factored into this action.
    Study Start Date
    September 2006 (undefined)
    Primary Completion Date
    January 2010 (Actual)
    Study Completion Date
    April 2010 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a Phase III, multicenter, global, clinical study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with follicular NHL. The purpose of the study is to compare the clinical benefit of galiximab when given in combination with rituximab as compared with rituximab alone (given with placebo) in subjects with follicular NHL. Safety and pharmacokinetics (PK) of galiximab and rituximab will also be evaluated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphoma, Non-Hodgkin's
    Keywords
    relapsed, NHL, pharmacokinetics, antibody, safety, galiximab, efficacy, rituximab, refractory

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    340 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Galiximab in combination with rituximab
    Intervention Description
    Galiximab (500mg/m2 IV) in combination with Rituximab (375 mg/m2 IV), weekly x 4
    Intervention Type
    Drug
    Intervention Name(s)
    Rituximab in combination with placebo
    Intervention Description
    Rituximab (375 mg/m2 IV) in combination with placebo, weekly x 4
    Primary Outcome Measure Information:
    Title
    To assess efficacy as measured by progression free survival (PFS), and determine whether rituximab plus galiximab compared to rituximab plus placebo may extend PFS.
    Time Frame
    The duration of this study is approx 4 years
    Secondary Outcome Measure Information:
    Title
    Secondary efficacy measures include: event-free survival, time to progression, duration of response, complete response rate, and overall survival.
    Time Frame
    The duration of this study is approx 4 years
    Title
    Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodies.
    Time Frame
    The duration of this study is approx 4 years
    Title
    Pharmacokinetics
    Time Frame
    The duration of this study is approx 4 years
    Title
    Quality of Life using both the Functional Assessment of Cancer Therapy-Lymphoma (FACT-lym) and the EQ-5D (EuroQoL) instruments
    Time Frame
    The duration of this study is approx 4 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Key Inclusion Criteria: Key Inclusion Criteria: Aged >= 18 years old at the time of informed consent. Histologically confirmed follicular Grade 1-3a NHL. Relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment. Bidimensionally measurable disease with at least 1 lesion >= 2.0 cm in a single dimension. Acceptable hematologic, hepatic, and renal function parameters. Recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, autologous bone marrow or stem cell transplant, or investigational drugs. Key Exclusion Criteria: Follicular lymphoma Grade 3b. Rituximab refractory or refractory to anti-CD20 radioimmunotherapy (no response to prior rituximab or prior rituximab-containing regimen, or a response with a TTP of less than 6 months). Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to Study Day 1 (6 weeks if nitrosourea or mitomycin C). Prior lymphoma vaccine therapy within 12 months prior to Study Day 1. Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to Study Day 1. Autologous bone marrow or stem cell transplant within 6 months prior to Study Day 1. Prior allogeneic transplant. Transfusion-dependent subjects. Another primary malignancy requiring active treatment (except hormonal therapy). Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions, which would compromise protocol objectives in the opinion of the Investigator and/or the Sponsor. New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to Study Day 1.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Biogen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study of Galiximab + Rituximab Versus Rituximab + Placebo in Follicular Non-Hodgkin's Lymphoma (NHL)

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