Rituximab Plus CHOP With Sargramostim in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Rituximab Plus CHOP Given Every Two Weeks With Sargramostim in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma|
- The primary endpoint in this trial will be tumor complete response (CR, CRu) to R-CHOP + GM-CSF, given every 14 days [ Time Frame: Every 2 cycles ] [ Designated as safety issue: Yes ]
- Response duration [ Time Frame: Every 2 cycles ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Rituximab 375 mg/m2 iv on day 1 q 15 days just prior to CHOP, beginning with cycle 1.
375 mg/m2 IV
|United States, California|
|USC Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90089|
|Principal Investigator:||Anil Tulpule, MD||University of Southern California|