A Randomized, Multicenter, Open Label, Phase 3 Study of Acalabrutinib (ACP-196) in Combination With Rituximab Versus Ibrutinib Versus Acalabrutinib Alone in Subjects With Relapsed or Refractory (R/R) Mantle Cell Lymphoma (MCL)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Progression-free survival (PFS) assessed by Independent Review Committee (IRC) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL). The primary analysis is a comparison of progression-free survival (PFS) between Arm 1 and Arm 2.
研究概览
简要总结
This study is evaluating the efficacy of acalabrutinib in combination with rituximab (Arm 1) versus ibrutinib (Arm 2) versus acalabrutinib (Arm 3) for the treatment of relapsed or refractory (R/R) mantle cell lymphoma (MCL).
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
- •Men and women ≥ 18 years of age.
- •Pathologically confirmed mantle cell lymphoma (MCL).
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤
- •Agreement to use highly effective forms of contraception during the study and for 90 days after the last dose of acalabrutinib or ibrutinib or 12 months after the last dose of rituximab (whichever is longest).
- •Disease that has relapsed, or been refractory to, ≥ 1 prior treatment regimen for mantle cell lymphoma (MCL).
- •Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
- •Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).
排除标准
- •Any history of central nervous system (CNS) lymphoma or leptomeningeal disease.
- •Prior exposure to ibrutinib or to a B-cell receptor (BCR) inhibitor.
- •Significant cardiovascular disease.
- •Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, 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.
- •Known history of infection with human immunodeficiency virus (HIV).
- •History of hepatitis B (HBV) infection or active infection with hepatitis C (HCV).
- •Breastfeeding or pregnant.
研究组 & 干预措施
acalabrutinib plus rituximab
Acalabrutinib will be orally administered until disease progression or unacceptable toxicity. Rituximab IV infusions will be administered weekly for 4 weeks and on Day 1 of Cycle 3 through 8, and thereafter every other cycle for less than or equal to two years (approximately 200 subjects).
干预措施: acalabrutinib (Drug)
acalabrutinib plus rituximab
Acalabrutinib will be orally administered until disease progression or unacceptable toxicity. Rituximab IV infusions will be administered weekly for 4 weeks and on Day 1 of Cycle 3 through 8, and thereafter every other cycle for less than or equal to two years (approximately 200 subjects).
干预措施: rituximab (Drug)
ibrutinib
Ibrutinib will be orally administered until disease progression or unacceptable toxicity (approximately 200 subjects).
干预措施: ibrutinib (Drug)
acalabrutinib
Acalabrutinib will be orally administered until disease progression or unacceptable toxicity (approximately 50 subjects).
干预措施: acalabrutinib (Drug)
结局指标
主要结局
Progression-free survival (PFS) assessed by Independent Review Committee (IRC) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL). The primary analysis is a comparison of progression-free survival (PFS) between Arm 1 and Arm 2.
时间窗: 48 months
次要结局
- Investigator-assessed progression-free survival (PFS) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL).(48 months)
- Investigator-assessed overall response rate (ORR) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL).(48 months)
- Overall survival (OS).(48 months)
- IRC-assessed duration of response (DOR) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL).(48 months)