A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

A vizsgálat adatai

Ki végzi

Loxo Oncology, Inc.

Azonosító

NCT05254743EU 2023-507699-38-00

A regiszteradat frissítve

2026. augusztus 17.

Eredeti leírás

The purpose of Part 1 of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL; participants may or may not have already had treatment for their cancer. The purpose of Part 2 of this study evaluates pirtobrutinib monotherapy in treatment-naïve participants with CLL/SLL with 17p deletions. Participation could last up to six years for Part 1. Participation could last up to 2 years for Part 2.A teljes eredeti leírásKevesebb

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)

The purpose of Part 1 of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL; participants may or may not have already had treatment for their cancer. The purpose of Part 2 of this study evaluates pirtobrutinib monotherapy in treatment-naïve participants with CLL/SLL with 17p deletions. Participation could last up to six years for Part 1. Participation could last up to 2 years for Part 2.

Bevonási feltételek: Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria; Part 1 - Known 17p deletion status (wildtype or deleted). Part 2 - Must have deletion of 17p as determined by FISH testing; Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; 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).

Kizáró feltételek: Previous treatment for CLL/SLL - Part 1: Treatment-naïve and previously treated, except prior exposure to BTK inhibitor (covalent or noncovalent); Part 2: participants must be treatment naïve; Concurrent use of investigational agent or anticancer therapy except hormonal therapy; 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; 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]); Active cytomegalovirus (CMV) infection; Active uncontrolled systemic bacterial, viral, or fungal infection; Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments; Ongoing inflammatory bowel disease; Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib; 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; Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count; Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment; Known or suspected central nervous system (CNS) involvement; Participants requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.

ClinicalTrials.gov NCT05254743 · EU CTIS 2023-507699-38-00