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

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ClinicalTrials.gov Identifier: NCT00148018
Recruitment Status : Terminated
First Posted : September 7, 2005
Last Update Posted : July 10, 2008
Information provided by:

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  (Clinical Trial)
Estimated Enrollment : 37 participants
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 : March 2005

Arms and Interventions

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00148018     History of Changes
Other Study ID Numbers: X05132
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: July 10, 2008
Last Verified: September 2006

Keywords provided by University of Cologne:
Hodgkin disease

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