jRCT2021210031进行中（未招募）不适用
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)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
- 主要终点
- progression-free survival (PFS)
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 as defined by iwCLL 2018 criteria.
- •Previously treated with a covalent BTK inhibitor.
- •Eastern Cooperative Oncology Group (ECOG) 0-
- •Absolute neutrophil count >= 0.75 x 10^9/L without granulocyte-colony-stimulating factor support, or >= 0.50 x 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 x 10^9/L. If an investigator has chosen bendamustine/rituximab as the Arm B treatment, platelets must be >= 75 x 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 ULN.
- •Estimated creatinine clearance of >= 30 mL/min.
排除标准
- •Known or suspected Richter's transformation at any time preceding enrollment.
- •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.
- •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:
- •Known hypersensitivity, including anaphylaxis, to any component or excipient of LOXO-
- •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.
结局指标
主要结局
progression-free survival (PFS)
时间窗: Up to approximately 36 months
To evaluate progression-free survival (PFS) of LOXO-305 monotherapy (Arm A) compared to investigator's choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) (Arm B) Assessed per iwCLL 2018
次要结局
未报告次要终点
研究者
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