A Phase 3, Randomized, Open-Label, Controlled, Multicenter Study of Zandelisib (ME- 401) in Combination With Rituximab Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non Hodgkin's Lymphoma (iNHL) - The COASTAL Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 82
- 试验地点
- 138
- 主要终点
- Progression Free Survival
研究概览
简要总结
This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL.
详细描述
This is an open label, randomized, two-arm Phase 3 study in subjects with relapsed or refractory FL and MZL to evaluate efficacy and safety of zandelisib in combination with rituximab in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP).
Subjects must have relapsed after at least one previous line of systemic immunochemotherapy. Previous treatments must have included an anti-CD20 monoclonal antibody (mAb) with chemotherapy such as Bendamustine (B), CHOP, CVP, FND, or similar regimens, or an anti-CD20 mAb with Lenalidomide (L).
Approximately 534 randomized subjects will be enrolled in this study.
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
- 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
- •Male or female subjects ≥18 years of age, ≥19 years in Korea, or ≥20 years for subjects in Japan and Taiwan
- •Histologically confirmed diagnosis of CD20 positive iNHL with histological subtype limited to:
- •FL Gr 1, Gr 2, or Gr 3a
- •MZL (splenic, nodal, or extra-nodal)
- •Subjects with relapsed or refractory disease who received ≥1 prior lines of therapy
- •Subjects must have at least one bi-dimensionally measurable lesion >1.5 cm
- •Adequate hematologic parameters at screening unless abnormal values are due to disease
- •Adequate renal and hepatic function
- •Adequate cardiac function based on ECG and LVEF assessments
排除标准
- •Histologically confirmed diagnosis of FL Gr 3b or transformed disease
- •Prior therapy with PI3K inhibitors
- •Ongoing or history of drug-induced pneumonitis
- •Known lymphomatous involvement of the central nervous system
- •Tested positive for or active viral infection with hepatitis B or C virus
- •Tested positive or active infection with human immunodeficiency virus
- •Tested positive, or active infection with human T-cell leukemia virus type 1
- •Any uncontrolled clinically significant illness
- •History of clinically significant cardiovascular abnormalities such as congestive heart failure
- •History of clinically significant gastrointestinal (GI) conditions
- •Females who are pregnant
研究组 & 干预措施
Rituximab plus Zandelisib
Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles
干预措施: Zandelisib (Drug)
Rituximab plus Zandelisib
Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles
干预措施: Rituximab (Drug)
Rituximab plus chemotherapy
Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles
干预措施: Rituximab (Drug)
Rituximab plus chemotherapy
Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles
干预措施: Bendamustine (Drug)
Rituximab plus chemotherapy
Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles
干预措施: CHOP (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 1 year 7 months
PFS is defined as the time from randomization date until the date of disease progression, or death from any cause
次要结局
- Overall Response Rate (ORR)(1 year 7 months)
- Complete Response Rate (CRR)(1 year 7 months)
- Overall Survival(1 year 7 months)
- Number of Treatment Emergent AEs (Zandelisib When Combined With Rituximab)(1 year 7 months)
- Number of SAEs (Zandelisib When Combined With Rituximab)(1 year 7 months)
- Number of Lab Abnormalities (Zandelisib When Combined With Rituximab)(1 year 7 months)