NCT00148018
Terminated
Phase 2
A Phase II Study of Bortezomib in Combination With Dexamethasone in Patients With Relapsed Hodgkin's Lymphoma
ConditionsHodgkin Disease
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Hodgkin Disease
- Sponsor
- University of Cologne
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Overall response rate (complete and partial responses)
- Status
- Terminated
- Last Updated
- 17 years ago
Overview
Brief Summary
The primary objective of this study is to evaluate wether bortezomib and dexamethasone are active in patients with relapsed Hodgkin's lymphoma.
Detailed Description
The proteasome-inhibitor bortezomib (Velcade) shows promising activity in various human lymphoma cell line. In addition, several studies in heavily pretreated patients with lymphoma showed also promising results.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Hodgkin's lymphoma
- •Second or higher relapse (first relapse if high-dose chemotherapy not possible)
- •Age \>/= 18 years
- •No major organ dysfunction or intercurrent disorder
- •Written informed consent
Exclusion Criteria
- •Pregnant or nursing
Outcomes
Primary Outcomes
Overall response rate (complete and partial responses)
Secondary Outcomes
- Toxicity
- Event free survival
- Overall survival
- Duration of response
- Treatment administration (dose-intensity, total dose)
Study Sites (1)
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