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

This study has been terminated.
German Hodgkin's Lymphoma Study Group
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:
University of Cologne Identifier:
First received: September 1, 2005
Last updated: July 9, 2008
Last verified: September 2006
The primary objective of this study is to evaluate wether bortezomib and dexamethasone are active in patients with relapsed Hodgkin's lymphoma.

Condition Intervention Phase
Hodgkin Disease
Drug: Bortezomib
Drug: Dexamethasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Bortezomib in Combination With Dexamethasone in Patients With Relapsed Hodgkin's Lymphoma

Resource links provided by NLM:

Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Overall response rate (complete and partial responses)

Secondary Outcome Measures:
  • Toxicity
  • Event free survival
  • Overall survival
  • Duration of response
  • Treatment administration (dose-intensity, total dose)

Estimated Enrollment: 37
Study Start Date: March 2005
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT00148018

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.
Principal Investigator: Andreas Engert University of Cologne
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00148018     History of Changes
Other Study ID Numbers: X05132 
Study First Received: September 1, 2005
Last Updated: July 9, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:
Hodgkin disease

Additional relevant MeSH terms:
Hodgkin Disease
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Protease Inhibitors processed this record on May 24, 2016