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Treatment of Advanced Hodgkin's Disease (Stages IIB-III-IV) (HD2000)

This study has been completed.
Sponsor:
Information provided by:
Gruppo Italiano Studio Linfomi
ClinicalTrials.gov Identifier:
NCT00443677
First received: March 5, 2007
Last updated: March 19, 2009
Last verified: March 2009
History of Changes
  Purpose

The purpose of this study is to compare the toxicities of the COPPEBVCAD vs BEACOPP vs ABVD regimens.


Condition Intervention Phase
Advanced Hodgkin Disease
 Drug: COPPEBVCAD vs BEACOPP vs ABVD
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Advanced Hodgkin's Disease (Stages IIB-III-IV)

Resource links provided by NLM:

MedlinePlus related topics: Hodgkin Disease
U.S. FDA Resources

Further study details as provided by Gruppo Italiano Studio Linfomi:

Primary Outcome Measures:
  • To compare the toxicity of the COPPEBVCAD vs BEACOPP vs ABVD regimens

Secondary Outcome Measures:
  • To compare the results in terms of response, failure free survival and relapse free survival of the three regimens

Enrollment: 307
Study Start Date: April 2000
Study Completion Date: June 2007
Arms Assigned Interventions
Active Comparator: abvd Drug: COPPEBVCAD vs BEACOPP vs ABVD
Experimental: beacopp Drug: COPPEBVCAD vs BEACOPP vs ABVD
Experimental: coppebvcad Drug: COPPEBVCAD vs BEACOPP vs ABVD

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of Hodgkin disease
  • Clinical stage IIB, III, IV
  • No prior treatment for Hodgkin disease or other malignancy
  • Age 18-65 year
  • Good cardiac, pulmunar, renal and hepatic function
  • Performance status 0-3 (Karnofsky 100- 40)
  • Written Informed Consent

Exclusion Criteria:

  • HIV positivity
  • Large cell, anaplastic, CD30+ lymphoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00443677

Locations
Italy
Centro Oncologico Modenese
Modena, Italy, 41100
Sponsors and Collaborators
Gruppo Italiano Studio Linfomi
Investigators
Principal Investigator: Paolo Gobbi, MD GISL
Principal Investigator: Emilio Iannitto, MD GISL
Principal Investigator: Giuseppe Polimeno, MD GISL
  More Information

No publications provided

Responsible Party: sponsor, Gruppo Italiano Studio Linfomi
ClinicalTrials.gov Identifier: NCT00443677     History of Changes
Other Study ID Numbers: HD2000
Study First Received: March 5, 2007
Last Updated: March 19, 2009
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on June 17, 2013