jRCT2021220024进行中（未招募）不适用
A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) versus Ibrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 650
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
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 (>=)50 x 10^9/liter (L) or >=30 x 10^9/L in participants with documented bone marrow involvement considered to impair hematopoiesis,
- •Hemoglobin >=8 grams/deciliter (g/dL) or >=6 g/dL in participants with documented bone marrow involvement considered to impair hematopoiesis
- •Absolute neutrophil count >=0.75 x 10^9/L or >=0.50 x 10^9/L in participants with documented bone marrow involvement considered to impair hematopoiesis
- •Kidney function: Estimated creatinine clearance >=30 milliliters per minute (mL/min)
排除标准
- •Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment
- •Known or suspected central nervous system (CNS) involvement
- •A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease
- •Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])
- •Significant cardiovascular disease including ejection fraction < 40% and any grade ongoing atrial fibrillation or atrial flutter
- •Hepatitis B or hepatitis C testing indicating active/ongoing infection, based on Screening laboratory tests
- •Active cytomegalovirus (CMV) infection
- •Active uncontrolled systemic bacterial, viral, or fungal infection
- •Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
- •Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments
- •Ongoing inflammatory bowel disease
- •Prior exposure to BTK inhibitor (covalent or noncovalent)
- •Concurrent use of investigational agent or anticancer therapy except hormonal therapy
- •Participants requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
- •Use of > 20 mg prednisone daily or equivalent dose of steroid at the time of first dose of study drug
- •Vaccination with a live vaccine within 28 days prior to randomization
- •Participants receiving chronic therapy with a strong cytochrome P450 (CYP)3A inhibitor (except posaconazole and voriconazole) which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment
- •Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: Baseline to best overall response at or before the initiation of subsequent anti-cancer therapy (if any) (approximately 3 years and 5 months)
Percentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (Cri), Nodular Partial Remission (nPR) or Partial Response (PR)
次要结局
未报告次要终点
研究者
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