HD12 for Advanced Stages

University of Cologne

Status and phase: Completed; Phase 3

Conditions: Hodgkin´s Lymphoma

Treatments: Drug: Procarbazine; Drug: Cyclophosphamide; Drug: Bleomycin; Drug: Vincristine; Drug: Prednisone; Procedure: radiation therapy; Drug: Adriamycin; Drug: Etoposide

Study type: Interventional

Funder types: Other

Identifiers

NCT00265031

HD12

Details and patient eligibility

About

This study is designed to test (1) whether the BEACOPP dosage can be reduced to baseline in the last 4 cycles without loss of effectiveness, and (2) whether consolidating irradiation is necessary following effective chemotherapy.

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hodgkin´s lymphoma (histologically proven)

• CS(PS) IIB with one or both of the risk factors:

  1. bulky mediastinal mass (> 1/3 of maximum transverse thorax diameter)
  2. extranodal involvement

• CS(PS) III, IV

• written informaed consent

Exclusion criteria

• Leukocytes <3000/microl
• Platelets <100000/microl
• Hodgkin´s Disease as "composite lymphoma"
• Activity index (WHO) < grade 2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)