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

• Sponsor: University of Cologne (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00148018
• Collaborator: German Hodgkin's Lymphoma Study Group (Other), Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)
• Enrollment: 37
• Location: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hodgkin Disease	Drug: Bortezomib; Drug: Dexamethasone	Phase 2

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 Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Bortezomib in Combination With Dexamethasone in Patients With Relapsed Hodgkin's Lymphoma
• Study Start Date: Mar 1, 2005

Outcome Measures

Primary Outcome Measures

1. Overall response rate (complete and partial responses) []

Secondary Outcome Measures

1. Toxicity []

2. Event free survival []

3. Overall survival []

4. Duration of response []

5. Treatment administration (dose-intensity, total dose) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Cologne	Cologne	NRW	Germany	50924

Sponsors and Collaborators

• University of Cologne
• German Hodgkin's Lymphoma Study Group
• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

• Principal Investigator: Andreas Engert, University of Cologne

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Description of study in German (Website of the Competence Network Malignant Lymphoma)

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00148018
• Other Study ID Numbers: X05132
• First Posted: Sep 7, 2005
• Last Update Posted: Jul 10, 2008
• Last Verified: Sep 1, 2006

• Keywords provided by , ,: Hodgkin disease; Bortezomib; Relapse; Lymphoma
• Additional relevant MeSH terms: Lymphoma; Hodgkin Disease; Dexamethasone; Bortezomib

Study Results

No Results Posted as of Jul 10, 2008