Clinical trial · Interventional
Phase II Study With Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Phase II Study With Rituximab and CHOP in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin's Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Gastric Diffuse-Large B-Cell Lymphoma | Gastric Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab + CHOP chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Complete remission rate
- timeFrame
- at end of chemo-immunotherapy
- measure
- Progression-free survival
- timeFrame
- at 2 and 5 years
Secondary outcomes (2)
- measure
- Overall survival
- timeFrame
- at 2 and 5 years
- measure
- Toxicity
- timeFrame
- after chemo-immunotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available