HD18 for Advanced Stages in Hodgkins Lymphoma

• Status: Completed
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to test:

1. in patients with negative positron-emission tomography (PET) after 2 cycles of BEACOPPesc chemotherapy: whether the number of cycles can be reduced without compromising progression free survival (PFS) (2 further cycles vs. 6 further cycles)

2. for patients with positive PET after 2 cycles: whether intensifying BEACOPPesc chemotherapy by adding Rituximab improves PFS.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cologne
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• Hodgkin Lymphoma (histologically proven)

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

• bulky mediastinal mass (> 1/3 of maximum transverse thorax diameter)

• extranodal involvement

• CS (PS) III, IV

• Written informed consent

Exclusion Criteria:

• Leucocytes < 3000/µl

• Platelets < 100000/µl

• Hodgkin´s lymphoma as "composite lymphoma"

• Activity index (WHO) < grade 2