jRCT2011210061进行中（未招募）不适用
A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) plus Venetoclax and Rituximab versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-322)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 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 per iwCLL 2018 criteria
- •Previous treatment with at least one line of therapy that may include a covalent Bruton's tyrosine kinase (BTK) inhibitor
- •Platelets greater than or equal to (>=)50 x 10^9/liter (L), hemoglobin >=8 grams/deciliter (g/dL) and absolute neutrophil count >=1.0 x 10^9/L
- •Adequate organ function
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- •Estimated creatinine clearance >=30 milliliters per minute (mL/min)
排除标准
- •Known or suspected Richter's transformation at any time preceding enrollment
- •Prior therapy with a 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
- •Prior therapy with venetoclax
- •Central nervous system (CNS) involvement
- •Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
- •Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
- •Allogeneic stem cell transplantation (SCT) or chimeric antigen receptor (CAR)-T within 60 days
- •Active hepatitis B or hepatitis C
- •Known active cytomegalovirus (CMV) infection
- •Uncontrolled immune thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA)
- •Significant cardiovascular disease
- •Vaccination with a live vaccine within 28 days prior to randomization
- •Patients with the following hypersensitivity:
- •Known hypersensitivity to any component or excipient of pirtobrutinib and venetoclax
- •Prior significant hypersensitivity to rituximab
- •Known allergy to allopurinol and inability to take uric acid lowering agent
结局指标
主要结局
progression-free survival (PFS)
时间窗: Up to approximately 5 years
To evaluate progression-free survival (PFS) of pirtobrutinib plus venetoclax and rituximab (Arm A) compared to venetoclax and rituximab (Arm B) Assessed by blinded independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018
次要结局
未报告次要终点
研究者
相似试验
招募中
2 期
Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) PatientsNon Hodgkin LymphomaHematologic MalignancyMantle Cell LymphomaNCT05529069M.D. Anderson Cancer Center30
进行中（未招募）
不适用
A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (J2N-OX-JZNP)jRCT2041210150Loxo Oncology, Inc.250
招募中
2 期
Pirtobrutinib (LOXO-305) and Venetoclax for the Treatment of Patients With CLL or SLL Resistant to Covalent BTKiSmall Lymphocytic LymphomaChronic Lymphocytic LeukemiaNCT06466122Kerry Rogers30
已完成
1 期
A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LOXO-305) and Digoxin (P-Glycoprotein Substrate) in Healthy ParticipantsHealthyNCT06194214Eli Lilly and Company16
招募中
2 期
Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-naïve Chronic Lymphocytic Leukemia (CLL) or Richter Transformation (RT)LeukemiaNCT05536349M.D. Anderson Cancer Center60