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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Study With Rituximab and CHOP in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin`s Lymphoma

Brief Summary: 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.

Detailed Summary: see above
Sponsor: University Hospital Tuebingen

Current Primary Outcome:

  • Complete remission rate [ Time Frame: at end of chemo-immunotherapy ]
  • Progression-free survival [ Time Frame: at 2 and 5 years ]


Original Primary Outcome:

  • Complete remission rate
  • progression-free survival at 2 and 5 years


Current Secondary Outcome:

  • Overall survival [ Time Frame: at 2 and 5 years ]
  • Toxicity [ Time Frame: after chemo-immunotherapy ]


Original Secondary Outcome:

  • overall survival at 2 and 5 years
  • Toxicity


Information By: University Hospital Tuebingen

Dates:
Date Received: September 14, 2005
Date Started: March 2003
Date Completion:
Last Updated: October 17, 2008
Last Verified: September 2008