A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (J2N-OX-JZNP)

Loxo Oncology, Inc.0 个研究点目标入组 250 人开始时间: 2021年12月9日最近更新: 2024年7月22日

试验速览

暂无简介。

•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 (>=)75 X 10^9/liter (L) (>=50 X 10^9/L for patients with evidence of bone marrow infiltrate), hemoglobin >=8 grams/deciliter (g/dL), and absolute neutrophil count >=0.75 X 10^9/L
•Kidney function: Estimated creatinine clearance >=40 milliliters per minute (mL/min)

•Known or suspected Richter's transformation at any time preceding enrollment
•Prior systemic therapy for CLL/SLL
•Presence of 17p deletion
•Central nervous system (CNS) involvement
•Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])
•Significant cardiovascular disease
•Active hepatitis B or hepatitis C
•Active cytomegalovirus (CMV) infection
•Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
•Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
•Concurrent use of investigational agent or anticancer therapy except hormonal therapy
•Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
•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 pirtobrutinib or bendamustine
•Prior significant hypersensitivity to rituximab

progression-free survival (PFS)

时间窗: Up to approximately 5 years

Assessed by blinded independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 Response Criteria

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