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

Gruppo Italiano Studio Linfomi

Status and phase: Completed; Phase 3

Conditions: Advanced Hodgkin Disease

Treatments: Drug: COPPEBVCAD vs BEACOPP vs ABVD

Study type: Interventional

Funder types: Other

Identifiers

NCT00443677

HD2000

Details and patient eligibility

About

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

Enrollment: 307 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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307 participants in 3 patient groups

abvd

Active Comparator group

Treatment:

Drug: COPPEBVCAD vs BEACOPP vs ABVD

beacopp

Experimental group

Treatment:

Drug: COPPEBVCAD vs BEACOPP vs ABVD

coppebvcad

Experimental group

Treatment:

Drug: COPPEBVCAD vs BEACOPP vs ABVD