NCT04965493进行中（未招募）3 期
A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab Versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-322)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 293
- 主要终点
- To evaluate progression-free survival (PFS) of pirtobrutinib plus venetoclax and rituximab (Arm A) compared to venetoclax and rituximab (Arm B)
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.
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
- •Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
- •Previous treatment with at least one line of therapy that may include a covalent Bruton's tyrosine kinase (BTK) inhibitor
- •Platelets greater than or equal to (≥)50 x 10⁹/liter (L), hemoglobin ≥8 grams/deciliter (g/dL) and absolute neutrophil count ≥1.0 x 10⁹/L
- •Adequate organ function
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- •Estimated creatinine clearance ≥30 milliliters per minute (mL/min)
排除标准
- •Known or suspected Richter's transformation at any time preceding enrollment
- •Prior therapy with a non-covalent (reversible) BTK inhibitor
- •Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
- •Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers
- •Prior therapy with venetoclax
- •Central nervous system (CNS) involvement
- •Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
- •Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
- •Allogeneic stem cell transplantation (SCT) or chimeric antigen receptor (CAR)-T within 60 days
- •Active hepatitis B or hepatitis C
- •Known active cytomegalovirus (CMV) infection
- •Uncontrolled immune thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA)
- •Significant cardiovascular disease
- •Vaccination with a live vaccine within 28 days prior to randomization
- •Patients with the following hypersensitivity:
- •Known hypersensitivity to any component or excipient of pirtobrutinib and venetoclax
- •Prior significant hypersensitivity to rituximab
- •Known allergy to allopurinol and inability to take uric acid lowering agent
研究组 & 干预措施
Arm A (PVR)
Experimental
Fixed duration pirtobrutinib in combination with venetoclax and rituximab
干预措施: Pirtobrutinib (Drug)
Arm A (PVR)
Experimental
Fixed duration pirtobrutinib in combination with venetoclax and rituximab
干预措施: Venetoclax (Drug)
Arm A (PVR)
Experimental
Fixed duration pirtobrutinib in combination with venetoclax and rituximab
干预措施: Rituximab (Drug)
Arm B (VR)
Active Comparator
Venetoclax with rituximab
干预措施: Venetoclax (Drug)
Arm B (VR)
Active Comparator
Venetoclax with rituximab
干预措施: Rituximab (Drug)
结局指标
主要结局
To evaluate progression-free survival (PFS) of pirtobrutinib plus venetoclax and rituximab (Arm A) compared to venetoclax and rituximab (Arm B)
时间窗: Up to approximately 5 years
Assessed by blinded independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018
次要结局
- To evaluate the efficacy of Arm A compared to Arm B: Progression-free survival (PFS)(Up to approximately 5 years)
- To evaluate the efficacy of Arm A compared to Arm B: Overall survival (OS)(Up to approximately 5 years)
- To evaluate the efficacy of Arm A compared to Arm B: Time to next treatment (TTNT)(Up to approximately 5 years)
- To evaluate the efficacy of Arm A compared to Arm B: Event-free survival (EFS)(Up to approximately 5 years)
- To evaluate the efficacy of Arm A compared to Arm B: Overall response rate (ORR)(Up to approximately 5 years)
- To evaluate the efficacy of Arm A compared to Arm B in patient-reported disease-related symptoms(Up to approximately 5 years)
- To evaluate the efficacy of Arm A compared to Arm B in patient-reported physical functioning(Up to approximately 5 years)
研究者
研究点 (293)
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