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A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
662 patients around the world
Available in Argentina, United States, Spain
Loxo Oncology, Inc.
22Research sites
662Patients around the world
This study is for people with
Leukemia
Chronic lymphocytic leukemia
Non-Hodgkin Lymphoma
Small lymphocytic lymphoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteriaEastern Cooperative Oncology Group (ECOG) Performance Status 0-2Adequate organ functionPlatelets 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 hematopoiesisAbsolute neutrophil count ≥0.75 x 10⁹/L or ≥0.50 × 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesisKidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL/min)
- Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollmentKnown or suspected central nervous system (CNS) involvementA significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic diseaseActive 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 flutterHepatitis B or hepatitis C testing indicating active/ongoing infection, based on Screening laboratory testsActive cytomegalovirus (CMV) infectionActive uncontrolled systemic bacterial, viral, or fungal infectionKnown human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) countClinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatmentsOngoing inflammatory bowel diseasePrior exposure to BTK inhibitor (covalent or noncovalent)Concurrent use of investigational agent or anticancer therapy except hormonal therapyParticipants requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonistUse of ≥ 20 mg prednisone daily or equivalent dose of steroid at the time of first dose of study drugVaccination with a live vaccine within 28 days prior to randomizationParticipants 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 treatmentParticipants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib
Sites
Hospital Privado de la Comunidad
Clínica de Nefrología Urología y Enfermedades Cardiovasculares - Santa Fe
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Hospital Santa Marcelina
Hospital das Clínicas da Faculdade de Medicina da São Paulo - USP
CIONC - Centro Integrado de Oncología de Curitiba
Hospital Erasto Gaertner
Centro de Estudos e Pesquisas de Hematologia e Oncologia - CEPHO
Hospital do Câncer de Cascavel - UOPECCAN
StudyBRUIN-CLL-314
SponsorLoxo Oncology, Inc.
Study typeInterventional
Conditions
Chronic lymphocytic leukemiaSmall lymphocytic lymphoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05254743
