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

Condition(s) targeted: Primary Gastric Diffuse-Large B-Cell Lymphoma

Intervention: Rituximab + CHOP chemotherapy (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University Hospital Tuebingen

Official(s) and/or principal investigator(s):
Wolfram Brugger, M.D., Principal Investigator, Affiliation: Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg

Overall contact:
Wolfram Brugger, M.D., Phone: +49-7721-93-4001, Email: wolfram.brugger@sbk-vs.de

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.

Official title: Phase II Study With Rituximab and CHOP in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin`s Lymphoma

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

complete remission rate

progression-free survival

Secondary outcome:

overall survival

toxicity

Detailed description: see above

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Wolfram Brugger, M.D., Phone: +49-7721-93-4001, Email: wolfram.brugger@sbk-vs.de

Schwarzwald-Baar Clinic, Villingen-Schwenningen 78050, Germany; Recruiting
Wolfram Brugger, M.D., Phone: +49-7721-93-4001, Email: wolfram.brugger@sbk-vs.de
Yasmin Hoffmann, Study Nurse, Phone: +49-7721-93-4001, Email: imo.studien@sbk-vs.de
Wolfram Brugger, M.D., Principal Investigator

Zentralklinikum Augsburg, Augsburg 86156, Germany; Recruiting
Günter Schlimok, M.D., Phone: 0821-400, Ext: 2285, Email: schlimok@klinikum-augsburg.de
Günter Schlimok, M.D., Principal Investigator

University of Tubingen, Tuebingen 72076, Germany; Recruiting
Lothar Kanz, M.D., Phone: +49-7071-2982726, Email: lothar.kanz@med.uni-tuebingen.de
Lothar Kanz, M.D., Principal Investigator

University of Freiburg Medical Center, Freiburg 79106, Germany; Not yet recruiting
Jürgen Finke, M.D., Phone: +49-761-270, Ext: 3679, Email: finke@mm11.ukl.uni-freiburg.de
Jürgen Finke, M.D., Principal Investigator

Mathias Rummel, Giessen, Germany; Recruiting
Mathias Rummel, MD

Starting date: March 2003
Ending date: September 2009
Last updated: June 6, 2008