Primary Gastric Diffuse-Large B-Cell Lymphoma Clinical Trial
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | September 2008 |
| Est. primary completion date | September 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Zentralklinikum Augsburg | Augsburg | |
| Germany | University of Giessen | Giessen | |
| Germany | Klinikum Reutlingen | Reutlingen | |
| Germany | University of Tubingen | Tuebingen | |
| Germany | Schwarzwald-Baar Clinic | Villingen-Schwenningen |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Tuebingen | Hoffmann-La Roche |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Complete remission rate | at end of chemo-immunotherapy | No | |
| Primary | Progression-free survival | at 2 and 5 years | No | |
| Secondary | Overall survival | at 2 and 5 years | No | |
| Secondary | Toxicity | after chemo-immunotherapy | Yes |