search
Back to results

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

Primary Purpose

Primary Gastric Diffuse-Large B-Cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Rituximab + CHOP chemotherapy
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Gastric Diffuse-Large B-Cell Lymphoma focused on measuring Rituximab, CHOP, DLBCL, gastric lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zentralklinikum Augsburg
  • University of Giessen
  • Klinikum Reutlingen
  • University of Tubingen
  • Schwarzwald-Baar Clinic

Outcomes

Primary Outcome Measures

Complete remission rate
Progression-free survival

Secondary Outcome Measures

Overall survival
Toxicity

Full Information

First Posted
September 14, 2005
Last Updated
October 17, 2008
Sponsor
University Hospital Tuebingen
Collaborators
Hoffmann-La Roche
search

1. Study Identification

Unique Protocol Identification Number
NCT00204659
Brief Title
Phase II Study With Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Official Title
Phase II Study With Rituximab and CHOP in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Tuebingen
Collaborators
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
see above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Gastric Diffuse-Large B-Cell Lymphoma
Keywords
Rituximab, CHOP, DLBCL, gastric lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rituximab + CHOP chemotherapy
Other Intervention Name(s)
MabThera
Intervention Description
standard Rituximab + CHOP chemo-immunotherapy
Primary Outcome Measure Information:
Title
Complete remission rate
Time Frame
at end of chemo-immunotherapy
Title
Progression-free survival
Time Frame
at 2 and 5 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
at 2 and 5 years
Title
Toxicity
Time Frame
after chemo-immunotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfram Brugger, M.D.
Organizational Affiliation
Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zentralklinikum Augsburg
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
University of Giessen
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Klinikum Reutlingen
City
Reutlingen
Country
Germany
Facility Name
University of Tubingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Schwarzwald-Baar Clinic
City
Villingen-Schwenningen
ZIP/Postal Code
78050
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs