Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2008

see above

Intervention(s) in this Clinical Trial

• Drug: Rituximab + CHOP chemotherapy
  • standard Rituximab + CHOP chemo-immunotherapy

Primary Measures

• complete remission rate
  • Time Frame: at end of chemo-immunotherapy
    Safety Issue?: No
• progression-free survival
  • Time Frame: at 2 and 5 years
    Safety Issue?: No

Secondary Measures

• overall survival
  • Time Frame: at 2 and 5 years
    Safety Issue?: No
• toxicity
  • Time Frame: after chemo-immunotherapy
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University Hospital Tuebingen

Overall Clinical Trial Officials and Contacts

Wolfram Brugger, M.D. Principal Investigator Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg  

Overall Contact: Wolfram Brugger, M.D. +49-7721-93-4001 wolfram.brugger@sbk-vs.de

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00204659

Study ID Number: 64-03

ClinicalTrials.gov Identifier: NCT00204659

Health Authority: Germany: Federal Institute for Drugs and Medical Devices