Randomized, Open Label, Phase II Trial Comparing Rituximab Plus Sargramostim to Rituximab Monotherapy for the Treatment of Relapsed Follicular B-cell Lymphoma
18 Years
N/A
Both
Lymphoma, Follicular
Trial Information
Randomized, Open Label, Phase II Trial Comparing Rituximab Plus Sargramostim to Rituximab Monotherapy for the Treatment of Relapsed Follicular B-cell Lymphoma
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 posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer
HealthCare, Inc.
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12
Outcome Description:
Count of number of participants who responded with a Complete Response (complete disappearance of all detectable clinical and radiological evidence of disease) at week 8 and again clinically and radiologically confirmed at week 12.
Outcome Time Frame:
Week 8 (confirmed at Week 12)
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Genzyme
Authority:
United States: Food and Drug Administration
Study ID:
310421
NCT ID:
NCT00308087
Start Date:
May 2006
Completion Date:
June 2009
Related Keywords:
- Lymphoma, Follicular
- Sargramostim
- Leukine
- NHL
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| Alexandria, Minnesota 56308 | |
| Birmingham, Alabama 35294 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Austin, Texas 78705 | |
| Indianapolis, Indiana |
