Comparison Study of Rituximab Plus Sargramostim to Rituximab Alone for Relapsed Follicular B-cell Lymphoma, a Form of Non-Hodgkin's Lymphoma
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma, Follicular
Intervention: Sargramostim (Leukine) (Drug); Rituximab (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Genzyme, a Sanofi Company Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company
Summary
The purpose of this study is to evaluate whether treatment with rituximab plus sargramostim
will be more effective than rituximab alone.
Clinical Details
Official title: Randomized, Open Label, Phase II Trial Comparing Rituximab Plus Sargramostim to Rituximab Monotherapy for the Treatment of Relapsed Follicular B-cell Lymphoma
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12
Secondary outcome: Summary of Treatment-Emergent Adverse Events (TEAE)Participant Summary of Best Response Across All Visits Kaplan-Meier Estimates of Progression-Free Survival Kaplan-Meier Estimates for Duration of Partial Response or Better to Treatment Summary of Cost Effectiveness
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
San Juan 00919, Puerto Rico
Birmingham, Alabama 35234, United States
Huntsville, Alabama 35805, United States
Los Angeles, California 90095, United States
Montebello, California 90640, United States
Pleasant Hill, California 94523, United States
Gainesville, Florida 32610-0254, United States
Jacksonville, Florida 32207, United States
Ocala, Florida 34474, United States
Tampa, Florida 33612, United States
Chicago, Illinois 60612, United States
Elk Grove Village, Illinois 60007, United States
Springfield, Illinois 62703, United States
Indianapolis, Indiana 46202, United States
New Albany, Indiana 47150, United States
Duluth, Minnesota 55805-1984, United States
Fresh Meadows, New York 11365, United States
New York, New York 10019, United States
Columbus, Ohio 43235, United States
Hershey, Pennsylvania 17033-0850, United States
Philadelphia, Pennsylvania 19104, United States
Houston, Texas 77030, United States
Additional Information
Starting date: May 2006
Last updated: December 2, 2013
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