Status:
UNKNOWN
HD16 for Early Stage Hodgkin Lymphoma
Lead Sponsor:
University of Cologne
Conditions:
Hodgkin Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of Progression free survival (PFS).
Eligibility Criteria
Inclusion
- Hodgkin Lymphoma
- CS I, II without risk factors
- large mediastinal mass (\> 1/3 of maximum transverse thorax diameter)
- extranodal involvement
- elevated ESR
- 3 or more involved nodal areas
- Written informed consent
Exclusion
- Leucocytes \< 3000/µl
- Platelets \< 100000/µl
- Hodgkin Lymphoma as composite lymphoma
- Activity index (WHO) \> 2
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
1150 Patients enrolled
Trial Details
Trial ID
NCT00736320
Start Date
November 1 2009
End Date
December 1 2021
Last Update
November 4 2020
Active Locations (1)
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1
1st Dept. of Medicine, Cologne University Hospital
Cologne, Germany