Phase II Study With Rituximab and CHOP in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 30
- Locations
- 5
- Primary Endpoint
- Complete remission rate
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 18 years
- •Histologically confirmed primary gastric CD20+ DLBCL
- •Written informed consent
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
Outcomes
Primary Outcomes
Complete remission rate
Time Frame: at end of chemo-immunotherapy
Progression-free survival
Time Frame: at 2 and 5 years
Secondary Outcomes
- Overall survival(at 2 and 5 years)
- Toxicity(after chemo-immunotherapy)