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

Advanced Hodgkin Disease Clinical Trial

— HD2000  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443677
• Other study ID #: HD2000
• Status: Completed
• Phase: Phase 3
• First received: March 5, 2007
• Last updated: March 19, 2009
• Start date: April 2000
• Est. completion date: June 2007

Study information

• Verified date: March 2009
• Source: Gruppo Italiano Studio Linfomi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Hodgkin Disease
• Hodgkin Disease

Intervention

Drug:
• COPPEBVCAD vs BEACOPP vs ABVD

Locations

Country	Name	City	State
Italy	Centro Oncologico Modenese	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Studio Linfomi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the toxicity of the COPPEBVCAD vs BEACOPP vs ABVD regimens
Secondary	To compare the results in terms of response, failure free survival and relapse free survival of the three regimens