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Clinical Trials/NCT00148018
NCT00148018
Terminated
Phase 2

A Phase II Study of Bortezomib in Combination With Dexamethasone in Patients With Relapsed Hodgkin's Lymphoma

University of Cologne1 site in 1 country37 target enrollmentMarch 2005

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.

Registry
clinicaltrials.gov
Start Date
March 2005
End Date
TBD
Last Updated
17 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

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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