A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Rituximab Versus Placebo in Combination With Rituximab in Treatment Naïve Subjects With Follicular Lymphoma (PERSPECTIVE)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 445
- 试验地点
- 128
- 主要终点
- Progression-Free Survival (PFS) as Assessed by Investigator
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study to evaluate the efficacy and safety of ibrutinib in combination with rituximab versus placebo in combination with rituximab in treatment naïve participants with follicular lymphoma (FL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of follicular lymphoma CD20+ (Grade 1, 2 or 3a) Ann Arbor Stage II, III or IV disease.
- •Measurable disease
- •Subjects 70 years of age or older; OR subjects 60-69 years of age who have one or more comorbidities.
- •Meets one or more Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
- •Adequate hematologic function within protocol-defined parameters.
- •Adequate hepatic and renal function within protocol-defined parameters.
- •ECOG performance status score of 0-2.
排除标准
- •Transformed lymphoma
- •Prior treatment for follicular lymphoma.
- •Central nervous system lymphoma or leptomeningeal disease.
- •Currently active, clinically significant cardiovascular disease.
研究组 & 干预措施
(Arm A) ibrutinib + rituximab
Participants to receive 560mg of ibrutinib once daily and rituximab 375mg/m^2 weekly x4 with maintenance.
干预措施: Ibrutinib Oral Capsule (Drug)
(Arm A) ibrutinib + rituximab
Participants to receive 560mg of ibrutinib once daily and rituximab 375mg/m^2 weekly x4 with maintenance.
干预措施: Rituximab (Drug)
(Arm B) placebo + rituximab
Participants to receive placebo once daily and rituximab 375mg/m^2 weekly x4 with maintenance.
干预措施: Placebo (Drug)
(Arm B) placebo + rituximab
Participants to receive placebo once daily and rituximab 375mg/m^2 weekly x4 with maintenance.
干预措施: Rituximab (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) as Assessed by Investigator
时间窗: Primary Analysis cut-off; median overall follow-up of 53.75 months
PFS is the time from the date of randomization to the date of the first documented evidence of disease progression (based on the Revised Response Criteria for Malignant Lymphoma \[Cheson 2014, Lugano Classification\]) or death from any cause, whichever occurs first. Participants who initiated subsequent anticancer therapy or missed two or more consecutive overall disease assessments were censored as described in the SAP. Estimated by Kaplan-Meier method.
次要结局
- Overall Response Rate (ORR) as Assessed by Investigator(Primary Analysis; median overall follow-up of 53.75 months)
- Overall Survival (OS)(Final Analysis; median overall follow-up of 58.97 months)
- Infusion-related Reaction Rate Assessed by Investigator(Primary Analysis; median overall follow-up of 53.75 months)
- Duration of Response (DOR) as Assessed by Investigator(Primary Analysis; median overall follow-up of 53.75 months)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(Overall median treatment duration of 22.11 months)