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
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TERMINATED
PHASE2
75 participants
INTERVENTIONAL
2006-05-31
2009-06-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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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
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Eligibility Criteria
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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
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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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
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Other Identifiers
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91499
Identifier Type: OTHER
Identifier Source: secondary_id
PREMIER
Identifier Type: OTHER
Identifier Source: secondary_id
310421
Identifier Type: -
Identifier Source: org_study_id