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OpenTrials
Completed

NCT Number: NCT00204659

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 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.

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Key information

Conditions

Primary Gastric Diffuse-Large B-Cell Lymphoma Familial primary gastric lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zentralklinikum Augsburg, Augsburg, Germany

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About this study

see above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab + CHOP chemotherapy

Drug

standard Rituximab + CHOP chemo-immunotherapy

Other names: MabThera

Primary outcomes

  1. Complete remission rate

    Time frame: at end of chemo-immunotherapy

  2. Progression-free survival

    Time frame: at 2 and 5 years

Secondary outcomes

  1. Overall survival

    Time frame: at 2 and 5 years

  2. Toxicity

    Time frame: after chemo-immunotherapy

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

Phase II Study With Rituximab and CHOP in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Sep 20, 2005
Registry last updated
Oct 20, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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