CTIS2023-507699-38-00进行中（未招募）1 期
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) - LOXO-BTK-20030
oxo Oncology Inc.0 个研究点目标入组 650 人开始时间: 2024年4月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 650
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 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?/liter (L) or =30 x 10?/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?/L or =0.50 × 10?/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., 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., 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.
研究者
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