Back to resultsComparison Study of Rituximab Plus Sargramostim to Rituximab Alone for Relapsed Follicular B-cell Lymphoma, a Form of Non-Hodgkin's Lymphoma (PREMIER)
Primary Purpose
Lymphoma, Follicular
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Sargramostim (Leukine)
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Follicular focused on measuring Sargramostim, Leukine, NHL
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Rituximab
Rituximab + Sargramostim
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Summary of Treatment-Emergent Adverse Events (TEAE)
Count of the number of participants who experienced treatment emergent adverse events (TEAEs). TEAEs occurred during the time study intervention was being taken occurring on or after Day 1 and no longer than 30 days after the last dose of study medication.
Participant Summary of Best Response Across All Visits
Count of participants' best response within categories defined by the International Working Group (IWG):
> Complete Response (complete disappearance of detectable clinical and radiological evidence of disease),
> Complete Response Unconfirmed (unconfirmed complete disappearance),
> Partial Response (>=50% decrease sum of the product of the greatest diameters in the six largest dominant nodes or nodal masses),
> Stable Disease (neither response nor disease progression),
> Progression (new lesion or increase by 50% of previously involved sites from nadir).
Kaplan-Meier Estimates of Progression-Free Survival
Time to event was measured from the date of randomization to the date of first progressive disease (PD) or death.
Kaplan-Meier Estimates for Duration of Partial Response or Better to Treatment
Count of days in which a participant experiences a Partial Response (>=50% decrease sum of the product of the greatest diameters in the six largest dominant nodes or nodal masses) or better. Time to event was measured from the date of response to the date of progressive disease (PD) or death.
Summary of Cost Effectiveness
A cost-effectiveness analysis from the payer perspective was to be performed. Only direct medical costs for each patient during the study period were to be included for analysis. Costs were to be calculated by multiplying each health care resource unit by the amount reimbursed by a payer. Health care resource utilization units are a way to normalize the quantity of health care provided to each participant so that costs can be compared.
Full Information
NCT ID
NCT00308087
First Posted
March 28, 2006
Last Updated
December 2, 2013
Sponsor
Genzyme, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00308087
Brief Title
Comparison Study of Rituximab Plus Sargramostim to Rituximab Alone for Relapsed Follicular B-cell Lymphoma, a Form of Non-Hodgkin's Lymphoma
Acronym
PREMIER
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 Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Terminated
Why Stopped
Terminated by sponsor due to low enrollment; see details below
Study Start Date
May 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Follicular
Keywords
Sargramostim, Leukine, NHL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rituximab
Arm Type
Active Comparator
Arm Title
Rituximab + Sargramostim
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sargramostim (Leukine)
Other Intervention Name(s)
Sargramostim, Leukine, Bay86-5326
Intervention Description
Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
Primary Outcome Measure Information:
Title
Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12
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.
Time Frame
Week 8 (confirmed at Week 12)
Secondary Outcome Measure Information:
Title
Summary of Treatment-Emergent Adverse Events (TEAE)
Description
Count of the number of participants who experienced treatment emergent adverse events (TEAEs). TEAEs occurred during the time study intervention was being taken occurring on or after Day 1 and no longer than 30 days after the last dose of study medication.
Time Frame
up to 12 weeks
Title
Participant Summary of Best Response Across All Visits
Description
Count of participants' best response within categories defined by the International Working Group (IWG):
> Complete Response (complete disappearance of detectable clinical and radiological evidence of disease),
> Complete Response Unconfirmed (unconfirmed complete disappearance),
> Partial Response (>=50% decrease sum of the product of the greatest diameters in the six largest dominant nodes or nodal masses),
> Stable Disease (neither response nor disease progression),
> Progression (new lesion or increase by 50% of previously involved sites from nadir).
Time Frame
up to 24 months
Title
Kaplan-Meier Estimates of Progression-Free Survival
Description
Time to event was measured from the date of randomization to the date of first progressive disease (PD) or death.
Time Frame
24 months
Title
Kaplan-Meier Estimates for Duration of Partial Response or Better to Treatment
Description
Count of days in which a participant experiences a Partial Response (>=50% decrease sum of the product of the greatest diameters in the six largest dominant nodes or nodal masses) or better. Time to event was measured from the date of response to the date of progressive disease (PD) or death.
Time Frame
24 months
Title
Summary of Cost Effectiveness
Description
A cost-effectiveness analysis from the payer perspective was to be performed. Only direct medical costs for each patient during the study period were to be included for analysis. Costs were to be calculated by multiplying each health care resource unit by the amount reimbursed by a payer. Health care resource utilization units are a way to normalize the quantity of health care provided to each participant so that costs can be compared.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35234
Country
United States
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
City
Pleasant Hill
State/Province
California
ZIP/Postal Code
94523
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0254
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805-1984
Country
United States
City
Fresh Meadows
State/Province
New York
ZIP/Postal Code
11365
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
San Juan
ZIP/Postal Code
00919
Country
Puerto Rico
12. IPD Sharing Statement
Learn more about this trial
Comparison Study of Rituximab Plus Sargramostim to Rituximab Alone for Relapsed Follicular B-cell Lymphoma, a Form of Non-Hodgkin's Lymphoma
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