NCT05023980进行中（未招募）3 期
A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 309
- 试验地点
- 108
- 主要终点
- To evaluate progression-free survival (PFS) of pirtobrutinib (Arm A) compared to bendamustine 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 pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. 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
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- •Adequate organ function
- •Platelets greater than or equal to (≥)75 x 10⁹/liter (L) (≥50 × 10⁹/L for patients with evidence of bone marrow infiltrate), hemoglobin ≥8 grams/deciliter (g/dL), and absolute neutrophil count ≥0.75 x 10⁹/L
- •Kidney function: Estimated creatinine clearance ≥40 milliliters per minute (mL/min)
排除标准
- •Known or suspected Richter's transformation at any time preceding enrollment
- •Prior systemic therapy for CLL/SLL
- •Presence of 17p deletion
- •Central nervous system (CNS) involvement
- •Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])
- •Significant cardiovascular disease
- •Active hepatitis B or hepatitis C
- •Active cytomegalovirus (CMV) infection
- •Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
- •Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
- •Concurrent use of investigational agent or anticancer therapy except hormonal therapy
- •Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
- •Vaccination with a live vaccine within 28 days prior to randomization
- •Patients with the following hypersensitivity:
- •Known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or bendamustine
- •Prior significant hypersensitivity to rituximab
研究组 & 干预措施
Arm A (Pirtobrutinib)
Experimental
Pirtobrutinib administered orally
干预措施: Pirtobrutinib (Drug)
Arm B (BR)
Active Comparator
Bendamustine plus rituximab administered intravenously (IV)
干预措施: Bendamustine (Drug)
Arm B (BR)
Active Comparator
Bendamustine plus rituximab administered intravenously (IV)
干预措施: Rituximab (Drug)
结局指标
主要结局
To evaluate progression-free survival (PFS) of pirtobrutinib (Arm A) compared to bendamustine 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 Response Criteria
次要结局
- To evaluate the effectiveness of Arm A compared to Arm B: Progression-free survival (PFS)(Up to approximately 5 years)
- To evaluate the effectiveness of Arm A compared to Arm B in patient-reported disease-related symptoms(Up to approximately 5 years)
- To evaluate the effectiveness of Arm A compared to Arm B: Time to next treatment (TTNT)(Up to approximately 5 years)
- To evaluate the effectiveness of Arm A compared to Arm B: Overall survival (OS)(Up to approximately 5 years)
- To evaluate the effectiveness of Arm A compared to Arm B: Overall response rate (ORR)(Up to approximately 5 years)
- To evaluate the effectiveness of Arm A compared to Arm B: Duration of Response (DOR)(Up to approximately 5 years)
- To evaluate the effectiveness of Arm A compared to Arm B in patient-reported physical functioning(Up to approximately 5 years)
研究者
研究点 (108)
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