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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00284271
First Posted: January 31, 2006
Last Update Posted: July 29, 2011
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.
Information provided by:
University of Cologne
  Purpose
This study is designed to test (1) feasibility and efficiancy of new BACOPP regimen and (2) toxicity, overall response and FFTF.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Enrollment: 65
Study Start Date: January 2004
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   61 Years to 75 Years   (Adult, Senior)
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
Information from the National Library of Medicine

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

Publications:
ClinicalTrials.gov Identifier: NCT00284271     History of Changes
Other Study ID Numbers: BACOPP-21
First Submitted: January 27, 2006
First Posted: January 31, 2006
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:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Prednisone
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