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

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

Study Overview

• Status: Terminated
• Conditions: Lymphoma, Follicular
• Intervention / Treatment: Drug: Rituximab; Drug: Sargramostim (Leukine)

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Rituximab	Drug: Rituximab; Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
EXPERIMENTAL: Rituximab + Sargramostim	Drug: Rituximab; Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks; 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: Leukine; Sargramostim; Bay86-5326

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 12 weeks
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).	up to 24 months
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.	24 months
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.	24 months
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.	24 months

Collaborators and Investigators

• Sponsor: Genzyme, a Sanofi Company

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (ACTUAL): June 1, 2009
• Study Completion (ACTUAL): June 1, 2009

Study Registration Dates

• First Submitted: March 28, 2006
• First Submitted That Met QC Criteria: March 28, 2006
• First Posted (ESTIMATE): March 29, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): December 27, 2013
• Last Update Submitted That Met QC Criteria: December 2, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: NHL; Sargramostim; Leukine
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, Follicular; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Rituximab; Sargramostim; Molgramostim
• Other Study ID Numbers: 310421; 91499 (OTHER: Genzyme); PREMIER (OTHER: Genzyme)