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Clinical Trials in the UK / NCT05254743
Recruiting Phase 3

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

NCT05254743 · tracked via the Priya Life Science UK tracker
Sponsor
Loxo Oncology, Inc.
Phase
Phase 3
Started
2022-07-22
Last updated
2026-08-17

Condition(s) studied

Chronic Lymphocytic LeukemiaLeukemia, LymphocyticLeukemia, B-cellSmall Lymphocytic Lymphoma

Investigational drug(s) / intervention(s)

PirtobrutinibIbrutinib

Pirtobrutinib: Administered orally.

Ibrutinib: Administered orally.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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) Exclusion Criteria: * 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 * 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 * Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments * Ongoing inflammatory bowel disease * 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 * 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

Primary outcome measure(s)

Trial sites (143)

FacilityCityRegionStatus
Pacific Cancer Medical Center, Inc Anaheim California Recruiting
TOI Clinical Research Cerritos California Recruiting
Stanford School of Medicine-Cancer Clinical Trials Office Palo Alto California Recruiting
California Cancer Associates for Research and Excellence San Marcos California Active Not Recruiting
Florida Cancer Specialists Fort Myers Florida Recruiting
Cancer Specialists of North Florida -St Augustine Saint Augustine Florida Recruiting
Florida Cancer Specialists East West Palm Beach Florida Recruiting
Hematology Oncology Clinic Baton Rouge Louisiana Active Not Recruiting
Tulane Cancer Center Office of Clinical Research New Orleans Louisiana Active Not Recruiting
American Oncology Partners of Maryland, PA Bethesda Maryland Recruiting
St. Vincent Frontier Cancer Center Billings Montana Recruiting
Cancer Care Associates Of York York Pennsylvania Active Not Recruiting
Prisma Health Cancer Institute Greenville South Carolina Active Not Recruiting
Sarah Cannon Research Institute SCRI Nashville Tennessee Recruiting
Kelsey Research Foundation Houston Texas Active Not Recruiting
Lumi Research Kingwood Texas Recruiting
Virginia Cancer Institute Richmond Virginia Recruiting
Medical Oncology Associates, PS Spokane Washington Recruiting
MultiCare Health System Institute for Research and Innovation Spokane Washington Active Not Recruiting
Alexander Fleming Ciudad Autónoma de Buenos Aire Argentina Recruiting
Hospital Privado De Comunidad Mar del Plata Argentina Active Not Recruiting
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares Santa Fe Argentina Recruiting
One Clinical Research Nedlands Australia Active Not Recruiting
Western Health, Sunshine Hospital St Albans Australia Active Not Recruiting
The Perth Blood Institute West Perth Australia Recruiting
Hanusch Krankenhaus Vienna Austria Active Not Recruiting
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Leuven Belgium Recruiting
VITAZ Sint-Niklaas Belgium Recruiting
Fundação Pio XII - Hospital de Câncer de Barretos Barretos Brazil Recruiting
Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP Botucatu Brazil Recruiting
Hemocentro Unicamp Campinas Brazil Recruiting
Hospital Uopeccan - Centro de Pesquisa Clinica Cascavel Brazil Recruiting
Centro Integrado de Oncologia de Curitiba Curitiba Brazil Active Not Recruiting
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer Curitiba Brazil Recruiting
Instituto do Câncer - Hospital São Vicente de Paulo Passo Fundo Brazil Recruiting
Centro Gaucho Integrado - Mae de Deus Center Porto Alegre Brazil Recruiting
Hospital de Clínicas de Ribeirão Preto Ribeirão Preto Brazil Recruiting
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia Santo André Brazil Recruiting
Centro Integrado de Pesquisa Clinica São José do Rio Preto Brazil Recruiting
Hospital BP São Paulo Brazil Recruiting

+ 103 more sites — see the full list on the official registry below.

On this site

📄 Imbruvica (ibrutinib) drug profile →

More Loxo Oncology, Inc. trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05254743 on ClinicalTrials.gov ↗ ← All trials in the UK