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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00284271
Recruitment Status : Completed
First Posted : January 31, 2006
Last Update Posted : July 29, 2011
Sponsor:
Information provided by:
University of Cologne

Study Description
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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
Hodgkin´s Lymphoma Drug: Cyclophosphamide Drug: Adramycin Drug: Procarbacine Drug: Prednisone Drug: Vincristine Drug: Bleomycin Drug: Erythropoietin beta Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2004
Actual Primary Completion Date : December 2005

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   61 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284271


Locations
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Germany
University of Cologne
Cologne, Germany, 50931
Sponsors and Collaborators
University of Cologne
Investigators
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Principal Investigator: Andreas Josting, Dr. University of Cologne
More Information
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Publications of Results:

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ClinicalTrials.gov Identifier: NCT00284271    
Other Study ID Numbers: BACOPP-21
First Posted: January 31, 2006    Key Record Dates
Last Update Posted: July 29, 2011
Last Verified: July 2011
Keywords provided by University of Cologne:
Hodgkin´s Lymphoma
eldery patients
primary diagnosis
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Prednisone
Cyclophosphamide
Vincristine
Bleomycin
Epoetin Alfa
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents