Comparison Study of Rituximab Plus Sargramostim to Rituximab Alone for Relapsed Follicular B-cell Lymphoma, a Form of Non-Hodgkin's Lymphoma
NCT ID: NCT00308087
Last Updated: 2013-12-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
75 participants
INTERVENTIONAL
2006-05-31
2009-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Vaccine Therapy and Sargramostim Compared With Placebo and Sargramostim Following Rituximab in Treating Patients With Non-Hodgkin's Lymphoma
NCT00089115
Vaccine Therapy and Sargramostim After Rituximab in Treating Patients With Refractory or Progressive Non-Hodgkin's Lymphoma
NCT00071955
Rituximab and GM-CSF in Treating Patients With Newly Diagnosed Follicular B-Cell Lymphoma
NCT00411086
A Study of Galiximab + Rituximab Versus Rituximab + Placebo in Follicular Non-Hodgkin's Lymphoma (NHL)
NCT00363636
Rituximab, Vaccine Therapy, and GM-CSF in Treating Patients With Non-Hodgkin's Lymphoma
NCT00258336
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study was terminated early due to low enrollment; significant changes to the protocol would have been required to keep pace with the changing therapeutic landscape of indolent lymphoma.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Rituximab
Rituximab
Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
Rituximab + Sargramostim
Sargramostim (Leukine)
Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab
Rituximab
Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sargramostim (Leukine)
Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab
Rituximab
Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* One or more previous therapies for non-Hodgkin's
* At least one measurable tumor by CT scan or MRI
* Additional criteria to be determined at screening visit
Exclusion Criteria
* Currently receiving treatment for another cancer
* Infection currently being treated
* Active Hepatitis B
* History of HIV infection
* Pregnant
* Additional criteria to be determined at screening visit
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Los Angeles, California, United States
Montebello, California, United States
Pleasant Hill, California, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Ocala, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Elk Grove Village, Illinois, United States
Springfield, Illinois, United States
Indianapolis, Indiana, United States
New Albany, Indiana, United States
Duluth, Minnesota, United States
Fresh Meadows, New York, United States
New York, New York, United States
Columbus, Ohio, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
San Juan, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
91499
Identifier Type: OTHER
Identifier Source: secondary_id
PREMIER
Identifier Type: OTHER
Identifier Source: secondary_id
310421
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.