Rituximab Plus CHOP With Sargramostim in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma
Status:
Unknown status
Trial end date:
2021-01-10
Target enrollment:
Participant gender:
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.