Phase II Study With Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin's Lymphoma
- Conditions
- Primary Gastric Diffuse-Large B-Cell Lymphoma
- Registration Number
- NCT00204659
- Lead Sponsor
- University Hospital Tuebingen
- 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 Description
see above
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Age > 18 years
- Histologically confirmed primary gastric CD20+ DLBCL
- Written informed consent
- ECOG 0-2
- Secondary aggressive Non-Hodgkin's lymphoma involving the gastric area
- HIV positive patients
- Severe organ dysfunction
- Life expectancy of less than 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Complete remission rate at end of chemo-immunotherapy Progression-free survival at 2 and 5 years
- Secondary Outcome Measures
Name Time Method Overall survival at 2 and 5 years Toxicity after chemo-immunotherapy
Trial Locations
- Locations (5)
University of Giessen
🇩🇪Giessen, Germany
Schwarzwald-Baar Clinic
🇩🇪Villingen-Schwenningen, Germany
Klinikum Reutlingen
🇩🇪Reutlingen, Germany
Zentralklinikum Augsburg
🇩🇪Augsburg, Germany
University of Tubingen
🇩🇪Tuebingen, Germany