Status:
TERMINATED
Comparison Study of Rituximab Plus Sargramostim to Rituximab Alone for Relapsed Follicular B-cell Lymphoma, a Form of Non-Hodgkin's Lymphoma
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Lymphoma, Follicular
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate whether treatment with rituximab plus sargramostim will be more effective than rituximab alone.
Detailed Description
On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. As of 29 August 2009, Genzyme assumed responsibility for the close out of the study. NOTE: This study was originally...
Eligibility Criteria
Inclusion
- Inclusion Criteria (abbreviated list):
- Relapsed follicular B-cell lymphoma
- 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 (abbreviated list):
- Rituximab refractory (less than 6 months from last treatment with rituximab to relapse)
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00308087
Start Date
May 1 2006
End Date
June 1 2009
Last Update
December 27 2013
Active Locations (22)
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1
Birmingham, Alabama, United States, 35234
2
Huntsville, Alabama, United States, 35805
3
Los Angeles, California, United States, 90095
4
Montebello, California, United States, 90640