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A-CHOP-14: Immunotherapy in Peripheral T Cell Lymphoma - the Role of Alemtuzumab in Addition to Dose Dense CHOP

Sponsor
University of Göttingen (Other)
Overall Status
Unknown status
CT.gov ID
NCT00725231
Collaborator
German High-Grade Non-Hodgkin's Lymphoma Study Group (Other), Nordic Lymphoma Group (Other)
274
Enrollment
1
Location
2
Arms
72.9
Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Peripheral T cell lymphomas comprise 10-15% of all malignant lymphomas. The prognosis is significantly worse than that of aggressive B cell lymphomas. The prospects of elderly patients are especially poor, with an estimated disease free survival of only 25% after three years. Previous phase II trials have demonstrated a significant activity of the monoclonal anti CD52 antibody alemtuzumab in primary and relapsed T cell lymphoma. The investigators thus propose to investigate the value of adjuvant alemtuzumab in combination with dose dense CHOP-14 in patients with previously untreated peripheral T cell lymphoma.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
274 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase III Study of CHOP-14 Plus or Minus Alemtuzumab in Peripheral T-cell Lymphoma of the Elderly
Study Start Date :
Feb 1, 2008
Anticipated Primary Completion Date :
Mar 1, 2014
Anticipated Study Completion Date :
Mar 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm A

Chemotherapy with dose dense CHOP-14, 6 cycles

Drug: chemotherapy
dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF
Other Names:
  • chemotherapy cylcophosphamide, hydroxyldaunorubicin

    		•
    Experimental: Arm B

    Chemotherapy with dose dense CHOP-14, 6-cycles, together with 30mg Alemtuzumab s.c. for the first 4 cycles

    Biological: alemtuzumab
    Addition of 30 mg Alemtuzumab by subcutaneous application for the first 4 cycles
    Other Names:
  • monoclonal anti CD52 antibody

    • Drug: chemotherapy
    dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF
    Other Names:
  • chemotherapy cylcophosphamide, hydroxyldaunorubicin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Event free survival [3 years]

    Secondary Outcome Measures

    1. Rate of complete and partial remissions [4 months after inclusion]

    2. treatment related deaths [time of occurence]

    3. Overall survival [@ 3 years]

    4. protocol adherence [4 months of treatment]

    5. immune reconstitution after alemtuzumab CHOP [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    61 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • all risk groups of peripheral T cell lymphoma

    • performance status ECOG 0-2

    • written consent

    • measurable disease

    Exclusion Criteria:

    • stage I N without bulky disease

    • already initiated treatment

    • serious accompanying disorder or impaired organ function

    • bone marrow involvement >25%

    • HIV positivity

    • leukemic manifestation of lymphoma

    • simultaneous participation in another trial

    • platelets < 100 000/ mm, leukocytes < 2500 /mm

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Göttingen Göttingen Lower Saxony Germany 37099

    Sponsors and Collaborators

    • University of Göttingen
    • German High-Grade Non-Hodgkin's Lymphoma Study Group
    • Nordic Lymphoma Group

    Investigators

    • Principal Investigator: Lorenz H Trümper, MD, University of Göttingen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Dr. Lorenz Trümper, Head of Departement of Haemtology and Oncology, University of Göttingen
    ClinicalTrials.gov Identifier:
    NCT00725231
    Other Study ID Numbers:
    • DSHNHL 2006-1B / ACT-2
    • BMBF GFVT 01014715
    First Posted:
    Jul 30, 2008
    Last Update Posted:
    May 7, 2012
    Last Verified:
    May 1, 2012
    Keywords provided by Prof. Dr. Lorenz Trümper, Head of Departement of Haemtology and Oncology, University of Göttingen
    T cell lymphoma
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, T-Cell
    Lymphoma, T-Cell, Peripheral
    Lymphoma, Extranodal NK-T-Cell
    Lymphadenopathy
    Immunoblastic Lymphadenopathy
    Alemtuzumab
    Doxorubicin
    Liposomal doxorubicin

    Study Results

    No Results Posted as of May 7, 2012