A Phase II Study of Bortezomib in Combination With Dexamethasone in Patients With Relapsed Hodgkin's Lymphoma
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Hodgkin Disease
Both
Hodgkin Disease
Trial Information
A Phase II Study of Bortezomib in Combination With Dexamethasone in Patients With Relapsed Hodgkin's Lymphoma
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall response rate (complete and partial responses)
Principal Investigator
Andreas Engert
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Cologne
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
X05132
NCT ID:
NCT00148018
Start Date:
March 2005
Completion Date:
Related Keywords:
- Hodgkin Disease
- Hodgkin disease
- Bortezomib
- Relapse
- Lymphoma
- Hodgkin Disease
- Lymphoma
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