Phase II Study With Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (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...
Brief Summary
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.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: September 2008
Detailed Clinical Trial Description
see above
Intervention(s) in this Clinical Trial
- Drug: Rituximab + CHOP chemotherapy
- standard Rituximab + CHOP chemo-immunotherapy
Outcome Measures for this Clinical Trial
Primary Measures
- Complete remission rate
- Time Frame: at end of chemo-immunotherapy
Safety Issue?: No
- Time Frame: at end of chemo-immunotherapy
- Progression-free survival
- Time Frame: at 2 and 5 years
Safety Issue?: No
- Time Frame: at 2 and 5 years
Secondary Measures
- Overall survival
- Time Frame: at 2 and 5 years
Safety Issue?: No
- Time Frame: at 2 and 5 years
- Toxicity
- Time Frame: after chemo-immunotherapy
Safety Issue?: Yes
- Time Frame: after chemo-immunotherapy
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: University Hospital Tuebingen Other
Overall Clinical Trial Officials and Contacts
Wolfram Brugger, M.D. Principal Investigator Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00204659
Study ID Number: 64-03
ClinicalTrials.gov Identifier: NCT00204659
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00204659
