Rituximab Plus CHOP With Sargramostim in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT00599170|
Recruitment Status : Active, not recruiting
First Posted : January 23, 2008
Last Update Posted : April 11, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Diffuse, Large B-Cell, Lymphoma||Drug: Rituximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rituximab Plus CHOP Given Every Two Weeks With Sargramostim in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma|
|Actual Study Start Date :||January 10, 2008|
|Estimated Primary Completion Date :||January 10, 2018|
|Estimated Study Completion Date :||January 10, 2019|
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
- 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 ]
- Response duration [ Time Frame: Every 2 cycles ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00599170
|United States, California|
|USC Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90089|
|Principal Investigator:||Anil Tulpule, MD||University of Southern California|