Study Stopped
Terminated by sponsor due to low enrollment; see details below
Comparison Study of Rituximab Plus Sargramostim to Rituximab Alone for Relapsed Follicular B-cell Lymphoma, a Form of Non-Hodgkin's Lymphoma
PREMIER
Randomized, Open Label, Phase II Trial Comparing Rituximab Plus Sargramostim to Rituximab Monotherapy for the Treatment of Relapsed Follicular B-cell Lymphoma
3 other identifiers
interventional
75
2 countries
22
Brief Summary
The purpose of this study is to evaluate whether treatment with rituximab plus sargramostim will be more effective than rituximab alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2006
Typical duration for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2006
CompletedFirst Posted
Study publicly available on registry
March 29, 2006
CompletedStudy Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
August 30, 2010
CompletedDecember 27, 2013
December 1, 2013
3.1 years
March 28, 2006
June 11, 2010
December 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12
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.
Week 8 (confirmed at Week 12)
Secondary Outcomes (5)
Summary of Treatment-Emergent Adverse Events (TEAE)
up to 12 weeks
Participant Summary of Best Response Across All Visits
up to 24 months
Kaplan-Meier Estimates of Progression-Free Survival
24 months
Kaplan-Meier Estimates for Duration of Partial Response or Better to Treatment
24 months
Summary of Cost Effectiveness
24 months
Study Arms (2)
Rituximab
ACTIVE COMPARATORRituximab + Sargramostim
EXPERIMENTALInterventions
Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab
Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Unknown Facility
Birmingham, Alabama, 35234, United States
Unknown Facility
Huntsville, Alabama, 35805, United States
Unknown Facility
Los Angeles, California, 90095, United States
Unknown Facility
Montebello, California, 90640, United States
Unknown Facility
Pleasant Hill, California, 94523, United States
Unknown Facility
Gainesville, Florida, 32610-0254, United States
Unknown Facility
Jacksonville, Florida, 32207, United States
Unknown Facility
Ocala, Florida, 34474, United States
Unknown Facility
Tampa, Florida, 33612, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Elk Grove Village, Illinois, 60007, United States
Unknown Facility
Springfield, Illinois, 62703, United States
Unknown Facility
Indianapolis, Indiana, 46202, United States
Unknown Facility
New Albany, Indiana, 47150, United States
Unknown Facility
Duluth, Minnesota, 55805-1984, United States
Unknown Facility
Fresh Meadows, New York, 11365, United States
Unknown Facility
New York, New York, 10019, United States
Unknown Facility
Columbus, Ohio, 43235, United States
Unknown Facility
Hershey, Pennsylvania, 17033-0850, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
San Juan, 00919, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
One hundred ninety-six patients were planned and 75 enrolled prior to termination. The study was terminated early due to low enrollment, and the extent of changes needed to the protocol to keep pace with therapeutic changes for indolent lymphoma.
Results Point of Contact
- Title
- Genzyme MedInfo
- Organization
- Genzyme Corporation
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2006
First Posted
March 29, 2006
Study Start
May 1, 2006
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
December 27, 2013
Results First Posted
August 30, 2010
Record last verified: 2013-12