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

• 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.
  
  

• 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.
  
  

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.