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HD12 for Advanced Stages

This study has been completed.
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00265031
First received: December 12, 2005
Last updated: June 22, 2012
Last verified: August 2007
History of Changes
  Purpose

This study is designed to test (1) whether the BEACOPP dosage can be reduced to baseline in the last 4 cycles without loss of effectiveness, and (2) whether consolidating irradiation is necessary following effective chemotherapy.


Condition Intervention Phase
Hodgkin´s Lymphoma
 Drug: Cyclophosphamide
Drug: Adriamycin
Drug: Etoposide
Drug: Procarbazine
Drug: Prednisone
Drug: Vincristine
Drug: Bleomycin
Procedure: radiation therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial 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:

Study Start Date: January 1999
  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hodgkin´s lymphoma (histologically proven)

  • CS(PS) IIB with one or both of the risk factors:

    1. bulky mediastinal mass (> 1/3 of maximum transverse thorax diameter)
    2. extranodal involvement
  • CS(PS) III, IV
  • written informaed 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: NCT00265031

Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Volker Diehl, Prof. University of Cologne
  More Information

Additional Information:
Description of study i German (Website of the Competence Network Malignant Lymphoma)  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00265031     History of Changes
Other Study ID Numbers: HD12
Study First Received: December 12, 2005
Last Updated: June 22, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:
Hodgkin´s Lymphoma
advanced stages

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bleomycin
Doxorubicin
Cyclophosphamide
Etoposide
Prednisone
Procarbazine
Vincristine
 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
Antineoplastic Agents, Phytogenic
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on May 19, 2013