A Phase 3 Clinical Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 758
- 试验地点
- 1
- 主要终点
- Overall Disease-Free Survival
研究概览
简要总结
This clinical research study is to investigate the prevention of relapse in patients with diffuse large B cell lymphoma (DLBCL) using enzastaurin daily.
This is a randomised trial which compares Enzastaurin to Placebo (dummy treatment), the chance of receiving Enzastaurin is 2 to 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Clinical diagnosis of diffuse large B cell lymphoma
- •Recently completed R-CHOP therapy and achieved remission
- •International Prognostic Index (IPI) score 3,4,5
- •At least 18 years of age
- •Agree to study follow-up schedule
排除标准
- •Have received therapy other than R-CHOP for lymphoma
- •Serious medical condition such as infection,second cancer,heart disease
- •Received radiation to more than one lesion
- •Unable to swallow tablets
研究组 & 干预措施
A
干预措施: enzastaurin (Drug)
B
干预措施: placebo (Drug)
结局指标
主要结局
Overall Disease-Free Survival
时间窗: Baseline to Measured Progressive Disease or Death from Any Cause (up to 80.30 months)
Overall Disease-Free Survival (DFS) time is defined as the time from the date of study enrollment to the first date of objectively determined disease recurrence (progressive disease) or death from any cause. DFS was assessed according to International Working Group recommendations. Progressive disease (PD) is defined as a ≥ 50% increase from the lowest point in the sum of the product of the diameters (SPD) of any previously identified abnormal node for partial or nonresponders, or the appearance of any new lesion during or at the end of therapy.
次要结局
- Disease Free Survival at 2 Years(Baseline to 2 Years)
- Event-Free Survival(Baseline to Objective PD, Start of New Therapy or Death From Any Cause (up to 76.81 months))
- Event-Free Survival at 2 Years(Baseline to 2 Years)
- Overall Survival(Baseline to Date of Death from Any Cause (up to 80.30 months))
- Number of Participants With Treatment-Emergent Adverse Events(First dose through 30 days post-study treatment discontinuation (up to 81.30 months))
- Quality of Life: Change From Baseline in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Score(Baseline, Month 2; Baseline, Month 4; Baseline, Month 6; Baseline, Month 12; Baseline, Month 18; Baseline, Month 24; Baseline, Month 36)
- Change From Baseline in EuroQol-5D (EQ-5D) Score(Baseline, Month 6; Baseline, Month 24; Baseline, Month 33)
- Translational Research: DFS Participants With Diffuse Large B-cell Lymphoma (DLBCL) Germinal-center B-cells (GCB) Versus Non-germinal-center B-cells(Baseline to 24 months (2 years))
- Translational Research: DFS of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Protein Kinase C-β2 (PKC-β2) Expression(Baseline to 94.5 months)
- Pharmacokinetics: Average Steady-State Concentration (Cavg,ss) for Total Analyte(Month 2, Month 4: Predose)