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

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: NCT00443677
Recruitment Status : Completed
First Posted : March 6, 2007
Last Update Posted : March 20, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to compare the toxicities of the COPPEBVCAD vs BEACOPP vs ABVD regimens.

Condition or disease Intervention/treatment Phase
Advanced Hodgkin Disease Drug: COPPEBVCAD vs BEACOPP vs ABVD Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 307 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Advanced Hodgkin's Disease (Stages IIB-III-IV)
Study Start Date : April 2000
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: sponsor, Gruppo Italiano Studio Linfomi
ClinicalTrials.gov Identifier: NCT00443677     History of Changes
Other Study ID Numbers: HD2000
First Posted: March 6, 2007    Key Record Dates
Last Update Posted: March 20, 2009
Last Verified: March 2009

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