A Multicenter, Phase III, Open-label Study Evaluating the Benefit of a Long-term Effect of MabThera (Rituximab) Maintenance Therapy in Patients With Advanced Follicular Lymphoma After Induction of Response (CR[u] or PR) With MabThera (Rituximab) Containing First-line Regimen
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 124
- 主要终点
- Event-free Survival
研究概览
简要总结
This study will evaluate the efficacy, safety, and tolerability of long-term maintenance therapy with rituximab in participants with advanced follicular lymphoma who have had a positive response to first-line treatment with a rituximab-containing regimen. The anticipated time on study treatment is 2 years, and the target sample size is 124 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adult participants greater than (>) 18 years of age
- •Histologically confirmed follicular lymphoma Grade 1, 2, or 3a with lymph node biopsy within 4 months of induction treatment
- •No previous anti-lymphoma treatment before induction chemotherapy (first-line-treated participants only are eligible)
- •Verified complete or partial remission after first-line induction therapy including rituximab
排除标准
- •Grade 3b follicular lymphoma
- •Transformation to high-grade lymphoma (except to Grade 3a) of previously existing follicular lymphoma
- •Presence of central nervous system lymphoma
- •Acquired immunodeficiency syndrome-related lymphoma
- •Other primary malignancy (other than squamous cell cancer of the skin or in situ cancer of the cervix) for which the participant has not been disease-free for greater than or equal to (>=) 5 years
研究组 & 干预措施
Rituximab
Participants will receive rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months or until progression, relapse, death, or institution of a new anti-lymphoma treatment.
干预措施: Rituximab (Drug)
结局指标
主要结局
Event-free Survival
时间窗: From randomization to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first, assessed up to 5 years
Event-free survival (EFS) was defined as the time from baseline (Week 0) to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first. Mean EFS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population (patients who received at least one maintenance MabThera infusion) was used for this analysis.
次要结局
- Time to Progression (TTP)(From baseline (Week 0) to disease progression, relapse, death from the follicular lymphoma or institution of a new regimen, whichever occurs first, assessed up to 5 years)
- Time to Next Anti-lymphoma Treatment (TTNLT)(From baseline (Week 0) to institution of a new antilymphoma regimen, assessed up to 5 years)
- Duration of Response (DR)(From first documented response to induction treatment to relapse or progression or death, assessed up to 5 years)
- Disease-free Survival (DFS)(From first documented complete response to induction treatment to relapse or progression or death, whichever occurs first, assessed up to 5 years)
- Number of Participants With Adverse Events (AEs)(Up to 27 months)
- Overall Survival (OS)(From randomization until death, assessed up to 5 years)