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

September 1, 2005
July 9, 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00148018
X05132
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