A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
NCT ID: NCT05254743
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
662 participants
INTERVENTIONAL
2022-07-22
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pirtobrutinib Part 1
Participants will receive pirtobrutinib orally.
Pirtobrutinib
Administered orally.
Ibrutinib
Participants will receive ibrutinib orally.
Ibrutinib
Administered orally.
Pirtobrutinib Part 2
Participants will receive pirtobrutinib orally.
Pirtobrutinib
Administered orally.
Interventions
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Pirtobrutinib
Administered orally.
Ibrutinib
Administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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 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
18 Years
ALL
No
Sponsors
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Loxo Oncology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Pacific Cancer Medical Center, Inc
Anaheim, California, United States
TOI Clinical Research
Cerritos, California, United States
Stanford School of Medicine-Cancer Clinical Trials Office
Palo Alto, California, United States
California Cancer Associates for Research and Excellence
San Marcos, California, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Cancer Specialists of North Florida -St Augustine
Saint Augustine, Florida, United States
Florida Cancer Specialists East
West Palm Beach, Florida, United States
Hematology Oncology Clinic
Baton Rouge, Louisiana, United States
Tulane Cancer Center Office of Clinical Research
New Orleans, Louisiana, United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland, United States
St. Vincent Frontier Cancer Center
Billings, Montana, United States
Cancer Care Associates of York
York, Pennsylvania, United States
Prisma Health Cancer Institute
Greenville, South Carolina, United States
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States
Kelsey Research Foundation
Houston, Texas, United States
Lumi Research
Kingwood, Texas, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Medical Oncology Associates, PS
Spokane, Washington, United States
MultiCare Health System Institute for Research and Innovation
Spokane, Washington, United States
Alexander Fleming
Ciudad Autónoma de Buenos Aire, , Argentina
Hospital Privado De Comunidad
Mar del Plata, , Argentina
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares
Santa Fe, , Argentina
One Clinical Research
Nedlands, , Australia
Western Health, Sunshine Hospital
St Albans, , Australia
The Perth Blood Institute
West Perth, , Australia
Hanusch Krankenhaus
Vienna, , Austria
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, , Belgium
VITAZ
Sint-Niklaas, , Belgium
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, , Brazil
Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP
Botucatu, , Brazil
Hemocentro Unicamp
Campinas, , Brazil
Hospital Uopeccan - Centro de Pesquisa Clinica
Cascavel, , Brazil
Centro Integrado de Oncologia de Curitiba
Curitiba, , Brazil
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
Curitiba, , Brazil
Instituto do Câncer - Hospital São Vicente de Paulo
Passo Fundo, , Brazil
Centro Gaucho Integrado - Mae de Deus Center
Porto Alegre, , Brazil
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto, , Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, , Brazil
Centro Integrado de Pesquisa Clinica
São José do Rio Preto, , Brazil
Hospital BP
São Paulo, , Brazil
Hospital da Clinicas da Faculdade de Medicina da USP
São Paulo, , Brazil
Hospital Santa Marcelina
São Paulo, , Brazil
Royal Victoria Hospital-Montreal
Montreal, , Canada
Hopital de L'Enfant Jesus
Québec, , Canada
Cancer Care Manitoba
Winnipeg, , Canada
Inmunocel
Santiago, , Chile
CeCim Biocinetic
Santiago, , Chile
Sociedad de Investigaciones Médicas Limitada
Temuco, , Chile
Centro de Investigaciones Clínicas Viña del Mar (CIC)
Viña del Mar, , Chile
The Second Xiangya Hospital of Central South University
Changsha, , China
Hunan Cancer Hospital
Changsha, , China
Sun Yat-sen University Cancer Center
Guangzhou, , China
Southern Medical University Nanfang Hospital
Guangzhou, , China
Hainan General Hospital
Haikou, , China
First Affiliated Hosp of College of Med, Zhejiang University
Hangzhou, , China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, , China
Anhui Provincial Hospital
Hefei, , China
The Second Hospital of Anhui Medical University
Hefei, , China
Jiangxi Provincial Cancer Hospital
Nanchang, , China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Blood Institute of the Chinese Academy of Medical science
Tianjin, , China
Tianjin Medical University General Hospital
Tianjin, , China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, , China
Wu Han Tongji Hospital
Wuhan, , China
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Yiwu, , China
Fakultni nemocnice Brno
Brno, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultni Nemocnice Ostrava
Ostrava, , Czechia
Fakultni Nemocnice Plzen
Pilsen, , Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
CHD Vendee
La Roche-sur-Yon, , France
Centre Hospitalier du Mans
Le Mans, , France
Centre Hospitalier Universitaire (Limoges) (CHU DUPUYTREN 1)
Limoges, , France
CHU de Nantes - Hotel Dieu
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
Hopital de la Pitie Salpetriere
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Hôpital de Pontchaillou
Rennes, , France
Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen
Rouen, , France
CHRU De Tours
Tours, , France
Gemeinschaftspraxis für Hämatologie und Onkologie (Gefos)
Dortmund, , Germany
Onkologische Gemeinschaftspraxis / BAG
Dresden, , Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden, Medizinische Klinik und Poliklinik 1
Dresden, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
Debrecen, , Hungary
Markusovszky Egyetemi Oktatokorhaz
Szombathely, , Hungary
Hadassah Medical Center
Jerusalem, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
Alessandria, , Italy
Policlinico Sant'Orsola Malpighi
Bologna, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
Azienda Unita Sanitaria Locale di Reggio Emilia
Reggio Emilia, , Italy
A.O.U. Citta' della Salute e della Scienza di Torino
Torino, , Italy
Kumamoto University Hospital
Kumamoto, , Japan
Yamagata University Hospital
Yamagata, , Japan
Dunedin Hospital
Dunedin, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Momentum Clinical Research
Newtown, , New Zealand
Middlemore Clinical Trials
Papatoetoe, , New Zealand
KO-MED Centra Kliniczne
Biała Podlaska, , Poland
Szpital Uniwersytecki nr 1 im. Antoniego Jurasza
Bydgoszcz, , Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Pratia Onkologia Katowice
Katowice, , Poland
Pratia MCM Krakow
Krakow, , Poland
Klinika Hematoonkologii i Transplantacji Szpiku,Samodzielny Publiczny Szpital Kliniczny Nr 1
Lublin, , Poland
AIDPORT Sp. z o.o.
Skórzewo, , Poland
Uniwersytecki Szpital Kliniczny Klinika
Wroclaw, , Poland
Inje Univ Busan Paik Hospital
Busan, , South Korea
The Catholic University of Korea-Seoul St. Mary's Hospital
Seocho-Gu, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Germans Trias i Pujol
Badalona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Institut Català d'Oncologia de Girona (ICO Girona)
Girona, , Spain
Hospital Duran i Reynals
L'Hospitalet de Llobregat, , Spain
Hospital De Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, , Spain
Hospital Universitario Infanta Leonor-INTERNAL MED
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, , Spain
Hospital Costa Del Sol
Marbella, , Spain
Clinica Universitaria De Navarra
Pamplona, , Spain
Hospital De Navarra
Pamplona, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Chang Bing Show Chwan Memorial Hospital
Changhua, , Taiwan
Chang Gung Memorial Hospital - Chiayi
Chiayi County, , Taiwan
National Cheng-Kung Uni. Hosp.
Tainan, , Taiwan
Koo Foundation Sun Yan-Sen Cancer Center
Taipei, , Taiwan
Gazi University Faculty of Medicine
Ankara, , Turkey (Türkiye)
9 Eylul University Hospital
Balçova, , Turkey (Türkiye)
Ege Üniversitesi
Bornova, , Turkey (Türkiye)
Istanbul University Istanbul Medicine Faculty
Faith, , Turkey (Türkiye)
American Hospital
Istanbul, , Turkey (Türkiye)
Acıbadem Maslak Hastanesi
Istanbul, , Turkey (Türkiye)
Ankara University Medicine Hospital
Mamak, , Turkey (Türkiye)
Bristol Haematology and Oncology Centre
Bristol, , United Kingdom
Castle Hill Hospital
Cottingham, , United Kingdom
HOPE Centre
Leicester, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
Singleton Hospital
Swansea, , United Kingdom
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Phone: 1-317-615-4559
Email: [email protected]
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Email: [email protected]
Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
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Related Links
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A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN-CLL-314)
Other Identifiers
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J2N-OX-JZNU
Identifier Type: OTHER
Identifier Source: secondary_id
LOXO-BTK-20030
Identifier Type: OTHER
Identifier Source: secondary_id
2023-507699-38-00
Identifier Type: CTIS
Identifier Source: secondary_id
18281
Identifier Type: -
Identifier Source: org_study_id