Hodgkins Lymphoma
Conditions
Keywords
Hodgkin lymphoma, PET, advances stages, Rituximab
Brief 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.
Interventions
addition of Rituximab to BEACOPP escalated
chemotherapy with BEACOPP escalated
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival | 5 years |
| acute toxicity | 5 years |
| late toxicity | 5 years |
| CR-rate | 5 years |
Countries
Germany