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CHO(E)P-14 Followed by Alemtuzumab Consolidation in Peripheral T Cell Lymphoma

Primary Purpose

Peripheral T-Cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Alemtuzumab
Sponsored by
University of Göttingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral T-Cell Lymphoma focused on measuring peripheral T cell lymphoma, alemtuzumab, consolidation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • all risk groups in international prognostic index
  • diagnosis of aggressive T-cell-lymphoma, confirmed by an excisional biopsy of a lymph node or by sufficiently extensive biopsy of an extranodal involvment, if there is no lymph node involvment.
  • these lymphomas comprise: peripheral T-cell lymphoma PTCL-NOS Lennert´s lymphoma T-zone lymphoma angioimmunoblastic T-cell-lymphoma
  • Performance status: ECOG (Eastern Cooperative Oncology Group Score) 0-3(Karnofsky index 40-100%)
  • written consent of the patient
  • Declaration of center participation

Exclusion Criteria:

  • Already initiated lymphoma therapy(exept for the prephase treatment specified for this study)
  • Serious accompanying disorder or impaired organ function
  • bone marrow involvement>25%
  • Known hypersensitivity to medications to be used
  • Know HIV-positivity
  • Active hepatitis infection, active CMV infection, prior florid tuberculosis
  • floride systemic infections
  • suspicion that patient compliance will be poor
  • Simultaneous participation in any the study protocol
  • prior chemo-or radiotherapy for malignancy
  • other concomitant malignant disease
  • Pregnancy or lactation period

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Alemtuzumab, antibody

    Arm Description

    alemtuzumab - anti CD 52 antibody administered as consolidation, total dose 133 mg

    Outcomes

    Primary Outcome Measures

    Feasibility of alemtuzumab consolidation after CHO(E)P 14 induction chemotherapy
    A descriptive approach for the primary endpoint was chosen: Adherence to schedule of alemtuzumab consolidation (number of cycles, dosing, time) - comparison of planned vs given in pts receiving alemtuzumab

    Secondary Outcome Measures

    rate of complete remissions
    Overall survival

    Full Information

    First Posted
    February 25, 2013
    Last Updated
    March 6, 2013
    Sponsor
    University of Göttingen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01806337
    Brief Title
    CHO(E)P-14 Followed by Alemtuzumab Consolidation in Peripheral T Cell Lymphoma
    Official Title
    Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab Consolidation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2003 (undefined)
    Primary Completion Date
    July 2006 (Actual)
    Study Completion Date
    February 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Göttingen

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab Consolidation
    Detailed Description
    Peripheral T cell lymphoma patients of all subtypes according to WHO are treated with an induction of 6 cycles of CHOP-etoposide-14 (if below 60 years of age) oder CHOP-14. If at least a PR is reached, consolidation with alemtuzumab, total dose 133 mg, is given i.v.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral T-Cell Lymphoma
    Keywords
    peripheral T cell lymphoma, alemtuzumab, consolidation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    41 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Alemtuzumab, antibody
    Arm Type
    Experimental
    Arm Description
    alemtuzumab - anti CD 52 antibody administered as consolidation, total dose 133 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Alemtuzumab
    Other Intervention Name(s)
    MabCampath
    Intervention Description
    Consolidation after CHOP induction
    Primary Outcome Measure Information:
    Title
    Feasibility of alemtuzumab consolidation after CHO(E)P 14 induction chemotherapy
    Description
    A descriptive approach for the primary endpoint was chosen: Adherence to schedule of alemtuzumab consolidation (number of cycles, dosing, time) - comparison of planned vs given in pts receiving alemtuzumab
    Time Frame
    average of 24 weeks (treatment duration)
    Secondary Outcome Measure Information:
    Title
    rate of complete remissions
    Time Frame
    at week 24 after initiation
    Title
    Overall survival
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: all risk groups in international prognostic index diagnosis of aggressive T-cell-lymphoma, confirmed by an excisional biopsy of a lymph node or by sufficiently extensive biopsy of an extranodal involvment, if there is no lymph node involvment. these lymphomas comprise: peripheral T-cell lymphoma PTCL-NOS Lennert´s lymphoma T-zone lymphoma angioimmunoblastic T-cell-lymphoma Performance status: ECOG (Eastern Cooperative Oncology Group Score) 0-3(Karnofsky index 40-100%) written consent of the patient Declaration of center participation Exclusion Criteria: Already initiated lymphoma therapy(exept for the prephase treatment specified for this study) Serious accompanying disorder or impaired organ function bone marrow involvement>25% Known hypersensitivity to medications to be used Know HIV-positivity Active hepatitis infection, active CMV infection, prior florid tuberculosis floride systemic infections suspicion that patient compliance will be poor Simultaneous participation in any the study protocol prior chemo-or radiotherapy for malignancy other concomitant malignant disease Pregnancy or lactation period
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lorenz Truemper
    Organizational Affiliation
    German High Grade Non Hodgkin´s Lymphoma Study Group
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    CHO(E)P-14 Followed by Alemtuzumab Consolidation in Peripheral T Cell Lymphoma

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