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

March 19, 2009 updated by: Gruppo Italiano Studio Linfomi
The purpose of this study is to compare the toxicities of the COPPEBVCAD vs BEACOPP vs ABVD regimens.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

307

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Modena, Italy, 41100
        • Centro Oncologico Modenese

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To compare the toxicity of the COPPEBVCAD vs BEACOPP vs ABVD regimens

Secondary Outcome Measures

Outcome Measure
To compare the results in terms of response, failure free survival and relapse free survival of the three regimens

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Studio Linfomi

Investigators

  • Principal Investigator: Paolo Gobbi, MD, GISL
  • Principal Investigator: Emilio Iannitto, MD, GISL
  • Principal Investigator: Giuseppe Polimeno, MD, GISL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2000

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

March 5, 2007

First Submitted That Met QC Criteria

March 5, 2007

First Posted (Estimate)

March 6, 2007

Study Record Updates

Last Update Posted (Estimate)

March 20, 2009

Last Update Submitted That Met QC Criteria

March 19, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD2000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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