Study of Bortezomib (Velcade) in Combination With Dexamethasone to Treat Patients With Relapsed Hodgkin's Lymphoma

Phase 2

Terminated

• Conditions: Hodgkin Disease

• Registration Number: NCT00148018
• Lead Sponsor: University of Cologne

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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-07
• Status Verified: 2006-09
• Last Update Submitted: 2008-07-09
• Last Update Posted: 2008-07-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall response rate (complete and partial responses)

Secondary Outcome Measures

Name	Time	Method
Toxicity
Event free survival
Overall survival
Duration of response
Treatment administration (dose-intensity, total dose)

Trial Locations

Locations (1)

University of Cologne; 🇩🇪 Cologne, NRW, Germany