Randomized, Open Label, Phase II Trial Comparing Rituximab Plus Sargramostim to Rituximab Monotherapy for the Treatment of Relapsed Follicular B-cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 75
- 主要终点
- Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12
研究概览
简要总结
The purpose of this study is to evaluate whether treatment with rituximab plus sargramostim will be more effective than rituximab alone.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Rituximab
干预措施: Rituximab (Drug)
Rituximab + Sargramostim
干预措施: Sargramostim (Leukine) (Drug)
Rituximab + Sargramostim
干预措施: Rituximab (Drug)
结局指标
主要结局
Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12
时间窗: 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.
次要结局
- 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)