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Feasibility and Efficacy of BACOPP-21 for Patients > 60 Years With Intermediate or Advanced Hodgkins Lymphoma

Sponsor
University of Cologne (Other)
Overall Status
Completed
CT.gov ID
NCT00284271
Collaborator
(none)
65
Enrollment
1
Location

Study Details

Study Description

Brief Summary

This study is designed to test (1) feasibility and efficiancy of new BACOPP regimen and (2) toxicity, overall response and FFTF.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Jan 1, 2004
Actual Primary Completion Date :
Dec 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    61 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Hodgkin´s lymphoma (histologically proven)

    • CS (PS) I and II with one of the risk factors a-d

    1. bulky mediastinal mass (> 1/3 maximum transverse thorax diameter)

    2. extranodal involvement

    3. ESR > 50 (A), > 30 (B-symptoms)

    4. 3 or more lymph node areas involved

    • CS (PS) III and IV

    • Written informed consent

    Exclusion Criteria:

    • Leukocytes <3000/microl

    • Platelets <100000/microl

    • Hodgkin´s Disease as "composite lymphoma"

    • Activity index (WHO) < grade 2

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Cologne Cologne Germany 50931

    Sponsors and Collaborators

    • University of Cologne

    Investigators

    • Principal Investigator: Andreas Josting, Dr., University of Cologne

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00284271
    Other Study ID Numbers:
    • BACOPP-21
    First Posted:
    Jan 31, 2006
    Last Update Posted:
    Jul 29, 2011
    Last Verified:
    Jul 1, 2011
    Keywords provided by , ,
    Hodgkin´s Lymphoma
    eldery patients
    primary diagnosis
    Additional relevant MeSH terms:
    Lymphoma
    Hodgkin Disease
    Prednisone
    Cyclophosphamide
    Vincristine
    Bleomycin
    Epoetin Alfa

    Study Results

    No Results Posted as of Jul 29, 2011