Randomized, Open Label, Phase II Trial Comparing Rituximab Plus Sargramostim to Rituximab Monotherapy for the Treatment of Relapsed Follicular B-cell Lymphoma
Overview
- Phase
- Phase 2
- Intervention
- Rituximab
- Conditions
- Lymphoma, Follicular
- Sponsor
- Genzyme, a Sanofi Company
- Enrollment
- 75
- Primary Endpoint
- Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Rituximab
Intervention: Rituximab
Rituximab + Sargramostim
Intervention: Sargramostim (Leukine)
Rituximab + Sargramostim
Intervention: Rituximab
Outcomes
Primary Outcomes
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)
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 Outcomes
- Summary of Treatment-Emergent Adverse Events (TEAE)(up to 12 weeks)
- Participant Summary of Best Response Across All Visits(up to 24 months)
- Kaplan-Meier Estimates of Progression-Free Survival(24 months)
- Kaplan-Meier Estimates for Duration of Partial Response or Better to Treatment(24 months)
- Summary of Cost Effectiveness(24 months)