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Phase II Study With Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin`s Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00204659
First received: September 14, 2005
Last updated: October 17, 2008
Last verified: September 2008
History of Changes

September 14, 2005
October 17, 2008
March 2003
September 2008   (final data collection date for primary outcome measure)
  • Complete remission rate [ Time Frame: at end of chemo-immunotherapy ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: at 2 and 5 years ] [ Designated as safety issue: No ]
  • complete remission rate
  • progression-free survival at 2 and 5 years
Complete list of historical versions of study NCT00204659 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: at 2 and 5 years ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: after chemo-immunotherapy ] [ Designated as safety issue: Yes ]
  • overall survival at 2 and 5 years
  • toxicity
Not Provided
Not Provided
 
Phase II Study With Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin`s Lymphoma
Phase II Study With Rituximab and CHOP in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin`s Lymphoma

The optimal treatment of primary gastric diffuse large B-cell lymphoma (PG-DLBCL) has not yet been defined. In most circumstances, a stomach-conserving approach is favored, but the role of radiotherapy is still a matter of debate. Recently, Rituximab along with full-dose CHOP chemotherapy has been shown to improve the outcome in elderly patients with nodal DLBCL. However, no data are available with such a therapy in patients with PG-DLBCL. Therefore, in March 2003, we initiated an ongoing, prospective, multicenter phase II study in patients with PG-DLBCL with 6 to 8 cycles of Rituximab (R; 375 mg/m2) plus CHOP-21 in order to evaluate the safety and efficacy of this approach.

see above
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Gastric Diffuse-Large B-Cell Lymphoma
Drug: Rituximab + CHOP chemotherapy
standard Rituximab + CHOP chemo-immunotherapy
Other Name: MabThera
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18 years
  • Histologically confirmed primary gastric CD20+ DLBCL
  • Written informed consent
  • ECOG 0-2

Exclusion Criteria:

  • Secondary aggressive Non-Hodgkin`s lymphoma involving the gastric area
  • HIV positive patients
  • Severe organ dysfunction
  • Life expectancy of less than 3 months
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00204659
64-03
No
Wolfram Brugger, M.D., Schwarzwald-Baar Clinic, Academic Teaching Hospital, Univ. Freiburg
University Hospital Tuebingen
Hoffmann-La Roche
Principal Investigator: Wolfram Brugger, M.D. Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg
University Hospital Tuebingen
September 2008

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