HD18 for Advanced Stages in Hodgkins Lymphoma
- Registration Number
- NCT00515554
- Lead Sponsor
- University of Cologne
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1500
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Rituximab 8 cycles BEACOPPesc plus rituximab A BEACOPP escalated 8 cycles BEACOPPesc B BEACOPP escalated 8 cycles BEACOPPesc plus rituximab C BEACOPP escalated 8 cycles BEACOPPesc D BEACOPP escalated 4 cycles BEACOPPesc
- Primary Outcome Measures
Name Time Method Progression Free Survival 5 years
- Secondary Outcome Measures
Name Time Method Overall Survival 5 years acute toxicity 5 years late toxicity 5 years CR-rate 5 years
Trial Locations
- Locations (1)
1st Dept. of Medicine, Cologne University Hospital
🇩🇪Cologne, Germany