NCT01153971已完成2 期
An Open-label Study of Fludarabine and Cyclophosphamide Plus MabThera Followed by Maintenance With MabThera on Failure-free Survival in Treatment-naïve Patients With Advanced Indolent B-cell Nonfollicular Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 15
- 主要终点
- Percentage of Participants Remaining Failure-Free After 2 Years From Treatment Start Date
研究概览
简要总结
This study will evaluate the efficacy and safety of MabThera in combination chemotherapy, followed by maintenance treatment with MabThera. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients 18-65 years of age;
- •previously untreated indolent nonfollicular non-Hodgkin's lymphoma;
- •active disease;
- •>=3 involved sites.
排除标准
- •typical chronic lymphocytic leukemia;
- •other malignancies within 3 years before study, except basal or squamous cell skin cancer or cancer in situ of the cervix;
- •systemic corticosteroid use for >1 month;
- •significant cardiovascular disease;
- •central nervous system involvement;
- •hepatitis B or C virus infection, or HIV infection.
研究组 & 干预措施
1
Experimental
干预措施: rituximab (Drug)
结局指标
主要结局
Percentage of Participants Remaining Failure-Free After 2 Years From Treatment Start Date
时间窗: Month 28
Percentage of participants who at 2 years from the start of treatment remained free from documented disease progression, relapse, or death. Failure status was based on tumor evaluation performed on Month 28. Participants who did not have a tumor evaluation at Month 28 were counted as failures.
次要结局
- Percentage of Participants Achieving a Best Overall Response of CR, CRu, or PR by Study Phase(Baseline, Months 4, 7 (Induction Phase), 11, 16 (Maintenance Phase),22, 28, 34, and 40(Follow-Up Phase))
- Percentage of Participants Achieving a Response by Response Type and Study Phase(Baseline, Months 4, 7, 11, 16, 22, 28, 34, and 40)
- Failure-Free Survival (FFS), Percentage of Participants Estimated to be Free of Documented Disease Progression, Relapse, or Death(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40)
- FFS - Percentage of Participants With an Event(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40)
- FFS - Time to Event(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40)
- Overall Survival (OS) - Percentage of Participants Estimated to be Alive(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40)
- OS - Percentage of Participants With an Event(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.)
- OS - Time to Event(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.)
- DFS - Percentage of Participants With an Event(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.)
- DFS - Time to Event(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.)
- Progression-free Survival (PFS) - Percentage of Participants Estimated to Be Progress Free(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40)
- PFS - Percentage of Participants With an Event(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40)
- PFS - Time to Event(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40)
- Duration of Response (DR) - Percentage of Participants Expected to Maintain a Response(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40)
- DR - Percentage of Participants With an Event(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40)
- Disease-Free Survival (DFS) - Percentage of Participants Estimated to be Disease-Free(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40)
- DR - Time to Event(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40)
研究者
研究点 (15)
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