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

University Hospital Tuebingen

Status and phase: Completed; Phase 2

Conditions: Primary Gastric Diffuse-Large B-Cell Lymphoma

Treatments: Drug: Rituximab + CHOP chemotherapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00204659

64-03

Details and patient eligibility

About

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.

Full description

see above

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)