search
Back to results

CD4 in Combination With CHOP in Treating Non-cutaneous Peripheral TCell Lymphoma

Primary Purpose

T-cell Lymphoma

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
CHOP + CD4
CHOP
Sponsored by
Emergent BioSolutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for T-cell Lymphoma focused on measuring non cutaneous peripheral t-cell lymphoma with nodal involvement

Eligibility Criteria

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

Inclusion Criteria:

  • study is closed to enrollment

Exclusion Criteria:

  • study is closed to enrollment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    CHOP chemo therapy + CD4 therapy

    CHOP chemotherapy

    Outcomes

    Primary Outcome Measures

    Primary Outcome Unavailable
    All efforts to obtain data have been exhausted, therefore we have no data available to report.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 5, 2009
    Last Updated
    October 23, 2023
    Sponsor
    Emergent BioSolutions
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00893516
    Brief Title
    CD4 in Combination With CHOP in Treating Non-cutaneous Peripheral TCell Lymphoma
    Official Title
    A Multicentre Open-label Dose Escalation Tiral of Zanolimumab in Combination With CHOP Chemotherapy in Patients With CD4 Positive Non-cutaneous Peripheral T-cell Lymphoma With Nodal Involvement.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Terminated
    Why Stopped
    Portfolio consolidation.
    Study Start Date
    May 2007 (undefined)
    Primary Completion Date
    October 2008 (Actual)
    Study Completion Date
    December 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Emergent BioSolutions

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Evaluation of CD4 in combination with CHO chemotherapy in subjects with nodal involvement of non cutaneous Tcell lymphoma.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    T-cell Lymphoma
    Keywords
    non cutaneous peripheral t-cell lymphoma with nodal involvement

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    5 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    CHOP chemo therapy + CD4 therapy
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    CHOP chemotherapy
    Intervention Type
    Biological
    Intervention Name(s)
    CHOP + CD4
    Intervention Type
    Drug
    Intervention Name(s)
    CHOP
    Primary Outcome Measure Information:
    Title
    Primary Outcome Unavailable
    Description
    All efforts to obtain data have been exhausted, therefore we have no data available to report.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: study is closed to enrollment Exclusion Criteria: study is closed to enrollment

    12. IPD Sharing Statement

    Learn more about this trial

    CD4 in Combination With CHOP in Treating Non-cutaneous Peripheral TCell Lymphoma

    We'll reach out to this number within 24 hrs