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.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00204659
First received: September 14, 2005
Last updated: October 17, 2008
Last verified: September 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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:
    Drug: Rituximab + CHOP chemotherapy
    standard Rituximab + CHOP chemo-immunotherapy
    Other Name: MabThera
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Zentralklinikum Augsburg
Augsburg, Germany, 86156
University of Giessen
Giessen, Germany, 35392
Klinikum Reutlingen
Reutlingen, Germany
University of Tubingen
Tuebingen, Germany, 72076
Schwarzwald-Baar Clinic
Villingen-Schwenningen, Germany, 78050
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: Wolfram Brugger, M.D., Schwarzwald-Baar Clinic, Academic Teaching Hospital, Univ. Freiburg
ClinicalTrials.gov Identifier: NCT00204659     History of Changes
Other Study ID Numbers: 64-03
Study First Received: September 14, 2005
Last Updated: October 17, 2008
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, Non-Hodgkin
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 18, 2014