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

This study has been terminated.
Sponsor:
Collaborators:
German Hodgkin's Lymphoma Study Group
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00148018
First received: September 1, 2005
Last updated: July 9, 2008
Last verified: September 2006
History of Changes
  Purpose

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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148018

Locations
Germany
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
  More Information

Additional Information:
Description of study in German (Website of the Competence Network Malignant Lymphoma)  This link exits the ClinicalTrials.gov site

No publications provided by University of Cologne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov 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
Bortezomib
Relapse
Lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Bortezomib
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
 Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013