A Phase 1b, Multicenter, Open-label Study of Acalabrutinib in Combination With Bendamustine and Rituximab (BR) or Venetoclax and Rituximab (VR) in Subjects With Mantle Cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 16
- 主要终点
- Number of Participants with Treatment Emergent Adverse Events (AEs) as assessed by CTCAE v4.03
研究概览
简要总结
A Phase 1b, Multicenter, Open-label Study of Acalabrutinib in Combination with Bendamustine and Rituximab (BR) or Venetoclax and Rituximab (VR) in Subjects with Mantle Cell Lymphoma
详细描述
This is a multicenter, open-label Phase 1b study to assess the safety and efficacy of acalabrutinib when administered concomitantly with bendamustine and rituximab in subjects with treatment naive or relapse refractory mantle cell lymphoma (Part 1), or when administered concomitantly with venetoclax and rituximab in subjects with treatment naive mantle cell lymphoma (Part 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Men and women ≥ 18 years of age.
- •Pathologically confirmed MCL.
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤
- •Agreement to use highly effective forms of contraception during the study and for 2 days after the last dose of acalabrutinib, 30 days after the last dose of venetoclax, or 12 months after the last dose of rituximab, whichever is longest.
- •Treatment Naive MCL patients requiring treatment with no exposure to prior therapies.
排除标准
- •Significant cardiovascular disease such as uncontrolled or untreated symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification.Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study
- •Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass
- •Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti-infective treatment within 2 weeks before first dose of study drug
- •Breastfeeding or pregnant
- •Concurrent participation in another therapeutic clinical trial.
研究组 & 干预措施
Part 1: Acalabrutinib+BR in TN patients
Part 1: Acalabrutinib in combination with drugs bendamustine and rituximab (BR) in treatment naive patients
干预措施: Acalabrutinib in combination with BR (Drug)
Part 2: Acalabrutinib+VR in TN patients
Part 2: Acalabrutinib in combination with venetoclax and rituximab (VR) in treatment naive patients
干预措施: Acalabrutinib in combination with VR (Drug)
Part 1: Acalabrutinib+BR in RR patients
Part 1: Acalabrutinib in combination with bendamustine and rituximab (BR) in relapse refractory patients
干预措施: Acalabrutinib in combination with BR (Drug)
结局指标
主要结局
Number of Participants with Treatment Emergent Adverse Events (AEs) as assessed by CTCAE v4.03
时间窗: From first dose of study drug to within 30 days of last dose of study drug
Number of participants who had experienced at least one treatment emergent AE
次要结局
未报告次要终点