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Rituximab Plus CHOP With Sargramostim in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma

Diffuse, Large B-Cell, Lymphoma Clinical Trial

Official title:
Rituximab Plus CHOP Given Every Two Weeks With Sargramostim in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma

Clinical Trial Summary

The use of R-CHOP, given every two weeks, will be associated with improvements in response rate, and progression-free survival, when compared to R-CHOP given every three weeks. The addition of sargramostim will allow safer adminIstration of the dose-intensified R-CHOP, while at the same time, improving the functional capability of the macrophages, and thus increasing the likelihood of improved clinical response and disease-free survival. The current phase II study is being proposed in order to develop preliminary data on the efficacy and toxicity of this approach, for future study in larger, phase III randomized trials. Laboratory correlates of response will also be studied, including activation markers on monocytes/macrophages before and after sargramostim exposure; and presence or absence of informative Fc gamma III polymorphisms.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00599170
Study type Interventional
Source University of Southern California
Contact
Status Completed
Phase Phase 2
Start date January 10, 2008
Completion date January 10, 2021
View Details
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