Back to resultsTreatment of Advanced Hodgkin's Disease (Stages IIB-III-IV) (HD2000)
Primary Purpose
Advanced Hodgkin Disease
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
COPPEBVCAD vs BEACOPP vs ABVD
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Hodgkin Disease
Eligibility 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
Sites / Locations
- Centro Oncologico Modenese
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
abvd
beacopp
coppebvcad
Arm Description
Outcomes
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
Full Information
NCT ID
NCT00443677
First Posted
March 5, 2007
Last Updated
March 19, 2009
Sponsor
Gruppo Italiano Studio Linfomi
1. Study Identification
Unique Protocol Identification Number
NCT00443677
Brief Title
Treatment of Advanced Hodgkin's Disease (Stages IIB-III-IV)
Acronym
HD2000
Official Title
Treatment of Advanced Hodgkin's Disease (Stages IIB-III-IV)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Gruppo Italiano Studio Linfomi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the toxicities of the COPPEBVCAD vs BEACOPP vs ABVD regimens.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Hodgkin Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
307 (Actual)
8. Arms, Groups, and Interventions
Arm Title
abvd
Arm Type
Active Comparator
Arm Title
beacopp
Arm Type
Experimental
Arm Title
coppebvcad
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
COPPEBVCAD vs BEACOPP vs ABVD
Primary Outcome Measure Information:
Title
To compare the toxicity of the COPPEBVCAD vs BEACOPP vs ABVD regimens
Secondary Outcome Measure Information:
Title
To compare the results in terms of response, failure free survival and relapse free survival of the three regimens
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Gobbi, MD
Organizational Affiliation
GISL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emilio Iannitto, MD
Organizational Affiliation
GISL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Giuseppe Polimeno, MD
Organizational Affiliation
GISL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Oncologico Modenese
City
Modena
ZIP/Postal Code
41100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Treatment of Advanced Hodgkin's Disease (Stages IIB-III-IV)
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