NCT00430352已完成4 期
A Study to Evaluate the Safety of MabThera (Rituximab) Maintenance Therapy in Patients With Follicular Non-Hodgkin's Lymphoma Who Have Responded to Induction Therapy.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 545
- 试验地点
- 177
- 主要终点
- Percentage of Participants With an Adverse Event (AE) - Overall Summary
研究概览
简要总结
This single arm study will evaluate the safety and efficacy of MabThera maintenance therapy following a MabThera-containing induction regimen in first line or relapsed patients with follicular non-Hodgkin's lymphoma. All patients will receive MabThera 375mg/m2 body surface area, as an intravenous infusion, every 8 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ 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 patients, >=18 years of age;
- •histologically confirmed grade 1, 2 or 3a follicular non-Hodgkin's lymphoma;
- •patients who have received adequate (>=8 cycles) induction therapy with MabThera as first line treatment, or treatment for relapsed disease;
- •demonstrated partial or complete response to induction therapy.
排除标准
- •stable or progressive disease after most recent induction therapy;
- •transformation to high grade lymphoma;
- •patients with prior or concomitant malignancies, except non-melanoma skin cancer or adequately treated in situ cancer of the cervix.
研究组 & 干预措施
1
Experimental
干预措施: rituximab [MabThera/Rituxan] (Drug)
结局指标
主要结局
Percentage of Participants With an Adverse Event (AE) - Overall Summary
时间窗: 24 months
Data presented include percentage of participants with any AE, any infusion-related AE, any serious adverse event (SAE), any infusion-related SAE (counted separately from SAEs), death, and participants with toxicity as the primary cause for treatment discontinuation.
次要结局
- Overall Survival (OS) - Time to Event(Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose)
- Progression-Free Survival - Percentage of Participants With an Event(Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose)
- Progression-Free Survival - Time to Event(Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose)
- Event-Free Survival (EFS) - Percentage of Participants With an Event(Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose)
- Event-Free Survival (EFS) - Time to Event(Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose)
- Overall Survival (OS) - Percentage of Participants With an Event(Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose)
- Time to Next Lymphoma Treatment (NLT) - Percentage of Participants With an Event(Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose)
- Time to NLT - Time to Event(Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose)
- Percentage of Participants With Response by Best Response to Study Treatment(Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose)
- Percentage of Participants With PR Who Converted to CRu(Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose)
研究者
研究点 (177)
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