CTIS2023-507697-40-00招募中1 期
A Phase 3 Open-Label, Randomized Study of LOXO-305 versus Investigator’s Choice of Idelalisib plus Rituximab or Bendamustine plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-321) - LOXO-BTK-20020
oxo Oncology Inc.0 个研究点目标入组 238 人开始时间: 2024年5月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 238
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
- •Age 18 or older per local regulations at time of enrollment., Estimated creatinine clearance of = 30 mL/min, Willing and capable of giving signed informed consent as described in Section 10.1.2 Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol., Confirmed diagnosis of CLL/SLL requiring therapy as defined by iwCLL 2018 criteria, Previously treated with a covalent BTK inhibitor, Eastern Cooperative Oncology Group (ECOG) 0 2, Absolute neutrophil count = 0.75 × 10^9/L without granulocyte colony stimulating factor support, or = 0.50 × 10^9/L in patients with documented bone marrow involvement considered to impair hematopoiesis. Granulocyte colony stimulating factor support is permitted in patients with documented bone marrow involvement, Hemoglobin = 8 g/dL or = 6 g/dL in patients with documented bone marrow involvement considered to impair hematopoiesis. Transfusion support is permitted in patients with bone marrow involvement, Platelets = 50 × 10^9/L. If an investigator has chosen bendamustine/rituximab as the Arm B treatment, platelets must be = 75 × 10^9/L. Patients may enroll below these thresholds if the Investigator determines the cytopenia is related to bone marrow involvement considered to impair hematopoiesis. Patients with a platelet count < 30 x 10^9/L are excluded, AST and ALT = 3.0 x upper limit of normal (ULN), Total bilirubin = 1.5 x
排除标准
- •Known or suspected Richter's transformation at any time preceding enrollment, Known Human Immunodeficiency Virus (HIV) infection, regardless of CD4 count, Clinically significant active malabsorption syndrome or inflammatory bowel disease, Prior exposure to 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, Vaccination with a live vaccine within 28 days prior to randomization, Patients with the following hypersensitivity: 1.Known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib. For patients planned to receive idelalisib, known hypersensitivity, including anaphylaxis, to any component or excipient of idelalisib. For patients planned to receive bendamustine, known hypersensitivity, including anaphylaxis, to any component or excipient of bendamustine. Prior significant hypersensitivity to rituximab, Known or suspected history of central nervous system (CNS) involvement by CLL/SLL, Ongoing drug induced liver injury, Active uncontrolled auto immune cytopenia, Significant cardiovascular disease, History of allogeneic or stem cell transplantation (SCT) or chimeric antigen receptor modified T cells (CAR T) therapy within the past 60 days, Active hepatitis B or hepatitis C, Known active cytomegalovirus (CMV) infection, Active uncontrolled systemic bacterial, viral, fungal or parasitic infection
研究者
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