Trial Information
HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma
Inclusion Criteria:
- Hodgkin Lymphoma
- CS I, II with risk factor (stage IIB with risk factor 1 or 2 are not included)
- large mediastinal mass (>1/3 of maximum transverse thorax diameter)
- extranodal involvement
- elevated ESR
- 3 or more involved nodal areas
- written informed consent
Exclusion Criteria:
- Leucocytes <3000/µl
- Platelets < 100000/µl
- Hodgkin Lymphoma as composite lymphoma
- Activity Index (WHO) >2
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Andreas Engert, Prof.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Cologne, German Hodgkin Study Group
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
HD17
NCT ID:
NCT01356680
Start Date:
December 2011
Completion Date:
December 2019
Related Keywords:
- Hodgkin Lymphoma
- Hodgkin Lymphoma
- intermediate stage
- PET
- Hodgkin Disease
- Lymphoma