2023-507699-38-00招募中3 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 Oncology Inc.55 个研究点 分布在 9 个国家目标入组 339 人开始时间: 2024年4月26日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 339
- 试验地点
- 55
- 主要终点
- Part 1 and Part 2: Primary endpoint: Overall response rate (ORR) as assessed by independent review committee (IRC) per iwCLL 2018 criteria. ORR is defined as the proportion of patients who achieve a BOR of CR, CRi, nPR, or PR at or before the initiation of subsequent anticancer therapy.
研究概览
简要总结
Part 1: To evaluate overall response rate (ORR) of pirtobrutinib (Arm A) compared to ibrutinib (Arm B)
Part 2: To evaluate ORR of pirtobrutinib in patients with del(17p) who are treatment naïve
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-
- •Adequate organ function • Platelets greater than or equal to (≥)50 x 10⁹/liter (L) or ≥30 x 10⁹/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 10⁹/L or ≥0.50 × 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis • Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL/min).
- •Part 1 - Known 17p deletion status (wildtype or deleted). Part 2 – Must have deletion of 17p as determined by FISH testing performed in a CLIA, ISO/IEC, CAP, or other similarly certified laboratory as per local guidelines, including, but not limited to, IVDR compliance as applicable.
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.
- •Part 1: Prior exposure to BTK inhibitor (covalent or noncovalent). Part 2: Prior therapy for CLL
- •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.
结局指标
主要结局
Part 1 and Part 2: Primary endpoint: Overall response rate (ORR) as assessed by independent review committee (IRC) per iwCLL 2018 criteria. ORR is defined as the proportion of patients who achieve a BOR of CR, CRi, nPR, or PR at or before the initiation of subsequent anticancer therapy.
Part 1 and Part 2: Primary endpoint: Overall response rate (ORR) as assessed by independent review committee (IRC) per iwCLL 2018 criteria. ORR is defined as the proportion of patients who achieve a BOR of CR, CRi, nPR, or PR at or before the initiation of subsequent anticancer therapy.
次要结局
未报告次要终点
研究者
Lilly Clinical Trials information desk
Scientific
Loxo Oncology Inc.
研究点 (55)
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