A Randomized, Open-label Study of MabThera Maintenance Therapy Compared With no Further Therapy After a Brief Induction With Chemotherapy Plus MabThera on Failure-free Survival in Treatment-naïve Elderly Patients With Advanced Follicular Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 45
- 主要终点
- Percentage of Participants With Disease Progression or Death
研究概览
简要总结
This study will evaluate the efficacy and safety of brief induction therapy with a chemotherapeutic regimen containing MabThera, followed by either maintenance therapy with MabThera or no further therapy. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 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
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients 60-75 years of age;
- •B-cell follicular NHL;
- •no previous treatment;
- •active disease, with rapid progression.
排除标准
- •other cancer within 3 years of study, except carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ of the breast treated with lumpectomy;
- •long-term use (>1 month) of systemic corticosteroids;
- •central nervous system involvement;
- •history of significant cardiovascular disease;
- •positive test result for HIV, or hepatitis B or C.
研究组 & 干预措施
1
干预措施: rituximab [Mabthera/Rituxan] (Drug)
结局指标
主要结局
Percentage of Participants With Disease Progression or Death
时间窗: 12, 24, and 34 months
PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. PFS function was estimated using Kaplan-Meier product-limit method. Responding participants and participants who were lost to follow up were censored at their last assessment date.
PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months
时间窗: 12, 24, and 34 months
PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. PFS was estimated using Kaplan-Meier methods.
次要结局
- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 36 Months(12, 24, and 36 months)
- Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months(12, 24, and 36 months)
- Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months(12, 24, and 34 months)
- Overall Survival (OS) From Randomization - Percentage of Participants With Death(12, 24, and 34 months)
- Percentage of Participants With a Response During the Induction Phase(Months 1 to 8)
- OS From Enrollment - Percentage of Participants Estimated to be Alive at 12, 24, and 36 Months(12, 24, and 36 months)
- Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months(Months 12, 24, and 34)
- Duration of Response Using the Competing Risk Approach - Cumulative Percentage of Participants With Progression, Relapse or Death as a Result of FL at 12, 24, and 34 Months(Months 12, 24, and 34)
- Percentage of Participants With a Molecular Response in the Induction Phase(Months 5 and 8)