Comparison Study of Rituximab Plus Sargramostim to Rituximab Alone for Relapsed Follicular B-cell Lymphoma, a Form of Non-Hodgkin's Lymphoma (PREMIER)

This study has been terminated.
(Terminated by sponsor due to low enrollment; see details below)
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00308087
First received: March 28, 2006
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to evaluate whether treatment with rituximab plus sargramostim will be more effective than rituximab alone.


Condition Intervention Phase
Lymphoma, Follicular
Drug: Sargramostim (Leukine)
Drug: Rituximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Open Label, Phase II Trial Comparing Rituximab Plus Sargramostim to Rituximab Monotherapy for the Treatment of Relapsed Follicular B-cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12 [ Time Frame: Week 8 (confirmed at Week 12) ] [ Designated as safety issue: No ]
    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) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]

    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 Frame: 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 75
Study Start Date: May 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rituximab Drug: Rituximab
Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
Experimental: Rituximab + Sargramostim Drug: Sargramostim (Leukine)
Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab
Other Names:
  • Sargramostim
  • Leukine
  • Bay86-5326
Drug: Rituximab
Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308087

Locations
United States, Alabama
Birmingham, Alabama, United States, 35234
Huntsville, Alabama, United States, 35805
United States, California
Los Angeles, California, United States, 90095
Montebello, California, United States, 90640
Pleasant Hill, California, United States, 94523
United States, Florida
Gainesville, Florida, United States, 32610-0254
Jacksonville, Florida, United States, 32207
Ocala, Florida, United States, 34474
Tampa, Florida, United States, 33612
United States, Illinois
Chicago, Illinois, United States, 60612
Elk Grove Village, Illinois, United States, 60007
Springfield, Illinois, United States, 62703
United States, Indiana
Indianapolis, Indiana, United States, 46202
New Albany, Indiana, United States, 47150
United States, Minnesota
Duluth, Minnesota, United States, 55805-1984
United States, New York
Fresh Meadows, New York, United States, 11365
New York, New York, United States, 10019
United States, Ohio
Columbus, Ohio, United States, 43235
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033-0850
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Houston, Texas, United States, 77030
Puerto Rico
San Juan, Puerto Rico, 00919
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00308087     History of Changes
Other Study ID Numbers: 310421, 91499, PREMIER
Study First Received: March 28, 2006
Results First Received: June 11, 2010
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Sargramostim
Leukine
NHL

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 19, 2014