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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:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00284271
First received: January 27, 2006
Last updated: July 28, 2011
Last verified: July 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   61 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 27, 2006
Last Updated: July 28, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:
Hodgkin´s Lymphoma
eldery patients
primary diagnosis

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bleomycin
Cyclophosphamide
Prednisone
Vincristine
Epoetin Alfa
Antibiotics, Antineoplastic
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Hematinics
Hematologic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 22, 2013