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
Results First Received: June 11, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma, Follicular
Interventions: Drug: Sargramostim (Leukine)
Drug: Rituximab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
One hundred ninety-six (196) patients were planned and 44 centers were open for enrollment. Eighty-two (82) patients were screened from 22 investigator sites across the United States and Puerto Rico.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
82 patients screened

Reporting Groups
  Description
Rituximab Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
Rituximab + Sargramostim Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.

Participant Flow:   Overall Study
    Rituximab     Rituximab + Sargramostim  
STARTED     37     38  
COMPLETED     1 [1]   1 [1]
NOT COMPLETED     36     37  
Progressive Disease                 19                 21  
Study Closure                 11                 12  
Withdrawal by Subject                 2                 1  
Not Specified                 4                 3  
[1] Completers finished treatment and the 24 month follow-up.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rituximab Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
Rituximab + Sargramostim Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
Total Total of all reporting groups

Baseline Measures
    Rituximab     Rituximab + Sargramostim     Total  
Number of Participants  
[units: participants]
  37     38     75  
Age  
[units: years]
Mean ± Standard Deviation
  61.5  ± 10.23     59.4  ± 8.68     60.5  ± 9.47  
Gender  
[units: participants]
     
Female     21     18     39  
Male     16     20     36  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     26     29     55  
Black     2     4     6  
Hispanic     7     3     10  
Asian     1     2     3  
Other     1     0     1  



  Outcome Measures
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1.  Primary:   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) ]

2.  Secondary:   Summary of Treatment-Emergent Adverse Events (TEAE)   [ Time Frame: up to 12 weeks ]

3.  Secondary:   Participant Summary of Best Response Across All Visits   [ Time Frame: up to 24 months ]

4.  Secondary:   Kaplan-Meier Estimates of Progression-Free Survival   [ Time Frame: 24 months ]

5.  Secondary:   Kaplan-Meier Estimates for Duration of Partial Response or Better to Treatment   [ Time Frame: 24 months ]

6.  Secondary:   Summary of Cost Effectiveness   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:  
Name/Title: Genzyme MedInfo
Organization: Genzyme Corporation
e-mail: medinfo@genzyme.com


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