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

This study has been completed.

First Received: September 14, 2005 Last Updated: October 17, 2008 History of Changes

Sponsor:	University Hospital Tuebingen
Collaborator:	Hoffmann-La Roche
Information provided by:	University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT00204659

Purpose

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.

Condition	Intervention	Phase
Primary Gastric Diffuse-Large B-Cell Lymphoma	Drug: Rituximab + CHOP chemotherapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study With Rituximab and CHOP in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin`s Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab

U.S. FDA Resources

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:

Complete remission rate [ Time Frame: at end of chemo-immunotherapy ] [ Designated as safety issue: No ]
Progression-free survival [ Time Frame: at 2 and 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Time Frame: at 2 and 5 years ] [ Designated as safety issue: No ]
Toxicity [ Time Frame: after chemo-immunotherapy ] [ Designated as safety issue: Yes ]

Enrollment:	30
Study Start Date:	March 2003
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Intervention Details:

standard Rituximab + CHOP chemo-immunotherapy

Detailed Description:

see above

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204659

Locations

Germany
Schwarzwald-Baar Clinic
Villingen-Schwenningen, Germany, 78050
Zentralklinikum Augsburg
Augsburg, Germany, 86156
University of Tubingen
Tuebingen, Germany, 72076
University of Giessen
Giessen, Germany, 35392
Klinikum Reutlingen
Reutlingen, Germany

Sponsors and Collaborators

University Hospital Tuebingen

Hoffmann-La Roche

Investigators

Principal Investigator:

Wolfram Brugger, M.D.

Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg

More Information

No publications provided

Responsible Party:	Schwarzwald-Baar Clinic, Academic Teaching Hospital, Univ. Freiburg ( Wolfram Brugger, M.D. )
Study ID Numbers:	64-03
Study First Received:	September 14, 2005
Last Updated:	October 17, 2008
ClinicalTrials.gov Identifier:	NCT00204659 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:

Rituximab
CHOP
DLBCL
gastric lymphoma

Additional relevant MeSH terms:

Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Rituximab
Physiological Effects of Drugs
Pharmacologic Actions

Lymphoma, B-Cell
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on February 08, 2010