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NCT00148018 Clinical Trial

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

Hodgkin Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00148018
Other study ID # X05132
Secondary ID
Status Terminated
Phase Phase 2
First received September 1, 2005
Last updated July 9, 2008
Start date March 2005

Study information
Verified date September 2006
Source University of Cologne
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate wether bortezomib and dexamethasone are active in patients with relapsed Hodgkin's lymphoma.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 37
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Bortezomib

• Dexamethasone

Locations
Country Name City State
Germany University of Cologne Cologne NRW

Sponsors (3)
Lead Sponsor Collaborator
University of Cologne German Hodgkin's Lymphoma Study Group, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall response rate (complete and partial responses)
Secondary Toxicity
Secondary Event free survival
Secondary Overall survival
Secondary Duration of response
Secondary Treatment administration (dose-intensity, total dose)
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