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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:
ClinicalTrials.gov Identifier:
NCT00148018
First Posted: September 7, 2005
Last Update Posted: July 10, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
German Hodgkin's Lymphoma Study Group
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:
University of Cologne
September 1, 2005
September 7, 2005
July 10, 2008
March 2005
Not Provided
Overall response rate (complete and partial responses)
Same as current
Complete list of historical versions of study NCT00148018 on ClinicalTrials.gov Archive Site
  • Toxicity
  • Event free survival
  • Overall survival
  • Duration of response
  • Treatment administration (dose-intensity, total dose)
Same as current
Not Provided
Not Provided
 
Study of Bortezomib (Velcade) in Combination With Dexamethasone to Treat Patients With Relapsed Hodgkin's Lymphoma
A Phase II Study of Bortezomib in Combination With Dexamethasone in Patients With Relapsed Hodgkin's Lymphoma
The primary objective of this study is to evaluate wether bortezomib and dexamethasone are active in patients with relapsed Hodgkin's lymphoma.
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.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hodgkin Disease
  • Drug: Bortezomib
  • Drug: Dexamethasone
Not Provided
Trelle S, Sezer O, Naumann R, Rummel M, Keller U, Engert A, Borchmann P. Bortezomib in combination with dexamethasone for patients with relapsed Hodgkin's lymphoma: results of a prematurely closed phase II study (NCT00148018). Haematologica. 2007 Apr;92(4):568-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
37
Not Provided
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00148018
X05132
Not Provided
Not Provided
Not Provided
Not Provided
University of Cologne
  • German Hodgkin's Lymphoma Study Group
  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Principal Investigator: Andreas Engert University of Cologne
University of Cologne
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP