Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Norris Comprehensive Cancer Center |
---|---|
Information provided by: | Norris Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00599170 |
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 | Intervention | Phase |
---|---|---|
Diffuse, Large B-Cell, Lymphoma |
Drug: Rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | Rituximab Plus CHOP Given Every Two Weeks With Sargramostim in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma |
Estimated Enrollment: | 50 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Female patients must have a negative pregnancy test within 72 hours of entering into the study. Both men and women will be included and, if of child bearing potential, must agree to use adequate contraception for the duration of the treatment. Women must avoid pregnancy and men avoid fathering children while in the study.
-
Exclusion Criteria:
Contact: Nancy Berman, RN | 323/865-3928 | Berman_N@ccnt.usc.edu |
United States, California | |
USC Norris Comprehensive Cancer Center | Recruiting |
Los Angeles, California, United States, 90089 | |
Principal Investigator: Anil Tulpule, MD |
Principal Investigator: | Anil Tulpule, MD | University of Southern California |
Responsible Party: | USC ( Anil Tulpule ) |
Study ID Numbers: | 13nhl-07-3 |
Study First Received: | January 11, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00599170 |
Health Authority: | United States: Institutional Review Board |
This is a standard phase II trial, in which patients with newly diagnosed diffuse large B cell lymphoma will receive R-CHOP with GM-CSF |
Lymphoma, large-cell Lymphoma, B-Cell Lymphatic Diseases Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders |
Rituximab B-cell lymphomas Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |