A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Start Date
7/22/2022
Completion Date
1/1/2028
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 Criteria
Age Range: 18 years to No maximum
Interventions
Pirtobrutinib
Ibrutinib
Conditions
Locations
Pacific Cancer Medical Center, Inc
Anaheim, California 92801
United States
TOI Clinical Research
Cerritos, California 90703
United States
Stanford School of Medicine-Cancer Clinical Trials Office
Palo Alto, California 94305
United States
California Cancer Associates for Research and Excellence
San Marcos, California 92069
United States
Florida Cancer Specialists
Fort Myers, Florida 33916-2233
United States
Cancer Specialists of North Florida -St Augustine
Saint Augustine, Florida 32086
United States
Florida Cancer Specialists East
West Palm Beach, Florida 33401
United States
Hematology Oncology Clinic
Baton Rouge, Louisiana 70809
United States
Tulane Cancer Center Office of Clinical Research
New Orleans, Louisiana 70112
United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland 20817
United States
St. Vincent Frontier Cancer Center
Billings, Montana 59102
United States
Cancer Care Associates of York
York, Pennsylvania 17403
United States
Prisma Health Cancer Institute
Greenville, South Carolina 29605
United States
Sarah Cannon Research Institute SCRI
Nashville, Tennessee 37203
United States
Kelsey Research Foundation
Houston, Texas 77025
United States
Lumi Research
Kingwood, Texas 77339
United States
Virginia Cancer Institute
Richmond, Virginia 23230
United States
Medical Oncology Associates, PS
Spokane, Washington 99208
United States
MultiCare Health System Institute for Research and Innovation
Spokane, Washington 99218
United States
Alexander Fleming
Ciudad Autónoma de Buenos Aire, C1426ANZ
Argentina
Hospital Privado De Comunidad
Mar del Plata, 7600
Argentina
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares
Santa Fe, 3000
Argentina
One Clinical Research
Nedlands, 6009
Australia
Western Health, Sunshine Hospital
St Albans, 3021
Australia
The Perth Blood Institute
West Perth, 6005
Australia
Hanusch Krankenhaus
Vienna, 1140
Austria
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000
Belgium
VITAZ
Sint-Niklaas, B-9100
Belgium
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, 14784400
Brazil
Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP
Botucatu, 18618-687
Brazil
Hemocentro Unicamp
Campinas, 13083-878
Brazil
Hospital Uopeccan - Centro de Pesquisa Clinica
Cascavel, 85806-300
Brazil
Centro Integrado de Oncologia de Curitiba
Curitiba, 80810050
Brazil
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
Curitiba, 81520060
Brazil
Instituto do Câncer - Hospital São Vicente de Paulo
Passo Fundo, 99010090
Brazil
Centro Gaucho Integrado - Mae de Deus Center
Porto Alegre, 90110270
Brazil
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto, 14051-140
Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, 09060-650
Brazil
Centro Integrado de Pesquisa Clinica
São José do Rio Preto, 15090-000
Brazil
Hospital BP
São Paulo, 01321-001
Brazil
Hospital da Clinicas da Faculdade de Medicina da USP
São Paulo, 05403-000
Brazil
Hospital Santa Marcelina
São Paulo, 08270-120
Brazil
Royal Victoria Hospital-Montreal
Montreal, H3A 1A1
Canada
Hopital de L'Enfant Jesus
Québec, G1J 1Z4
Canada
Cancer Care Manitoba
Winnipeg, R3E 0V9
Canada
Inmunocel
Santiago, 7580206
Chile
CeCim Biocinetic
Santiago, 8320000
Chile
Sociedad de Investigaciones Médicas Limitada
Temuco, 4780000
Chile
Centro de Investigaciones Clínicas Viña del Mar (CIC)
Viña del Mar, 2520000
Chile
The Second Xiangya Hospital of Central South University
Changsha, 410011
China
Hunan Cancer Hospital
Changsha, 410013
China
Sun Yat-sen University Cancer Center
Guangzhou, 510060
China
Southern Medical University Nanfang Hospital
Guangzhou, 510515
China
Hainan General Hospital
Haikou, 570311
China
First Affiliated Hosp of College of Med, Zhejiang University
Hangzhou, 310003
China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, 310009
China
Anhui Provincial Hospital
Hefei, 230001
China
The Second Hospital of Anhui Medical University
Hefei, 231200
China
Jiangxi Provincial Cancer Hospital
Nanchang, 330029
China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, 530021
China
Fudan University Shanghai Cancer Center
Shanghai, 200032
China
Blood Institute of the Chinese Academy of Medical science
Tianjin, 300020
China
Tianjin Medical University General Hospital
Tianjin, 300052
China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, 830000
China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022
China
Wu Han Tongji Hospital
Wuhan, 430030
China
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Yiwu, 322000
China
Fakultni nemocnice Brno
Brno, 62500
Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
Czechia
Fakultni Nemocnice Ostrava
Ostrava, 708 52
Czechia
Fakultni Nemocnice Plzen
Pilsen, 305 99
Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 10034
Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 12808
Czechia
CHD Vendee
La Roche-sur-Yon, 85000
France
Centre Hospitalier du Mans
Le Mans, 72000
France
Centre Hospitalier Universitaire (Limoges) (CHU DUPUYTREN 1)
Limoges, 87042
France
CHU de Nantes - Hotel Dieu
Nantes, 44093
France
Centre Antoine Lacassagne
Nice, 06189
France
Hopital de la Pitie Salpetriere
Paris, 75651
France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
France
Hôpital de Pontchaillou
Rennes, 35033
France
Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen
Rouen, 76038
France
CHRU De Tours
Tours, 37044
France
Gemeinschaftspraxis für Hämatologie und Onkologie (Gefos)
Dortmund, 44309
Germany
Onkologische Gemeinschaftspraxis / BAG
Dresden, 01307
Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden, Medizinische Klinik und Poliklinik 1
Dresden, 01307
Germany
Universitätsklinikum Ulm
Ulm, 89075
Germany
Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
Debrecen, 4004
Hungary
Markusovszky Egyetemi Oktatokorhaz
Szombathely, 9700
Hungary
Hadassah Medical Center
Jerusalem, 9112001
Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Israel
Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
Alessandria, 15100
Italy
Policlinico Sant'Orsola Malpighi
Bologna, 40138
Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, 47014
Italy
IRCCS Ospedale San Raffaele
Milan, 20132
Italy
Istituto Europeo di Oncologia
Milan, 20141
Italy
Azienda Unita Sanitaria Locale di Reggio Emilia
Reggio Emilia, 42122
Italy
Kumamoto University Hospital
Kumamoto, 860-8556
Japan
Yamagata University Hospital
Yamagata, 990-9585
Japan
Dunedin Hospital
Dunedin, 9016
New Zealand
Waikato Hospital
Hamilton, 3204
New Zealand
Momentum Clinical Research
Newtown, 6242
New Zealand
Middlemore Clinical Trials
Papatoetoe, 2025
New Zealand
KO-MED Centra Kliniczne
Biała Podlaska, 21500
Poland
Szpital Uniwersytecki nr 1 im. Antoniego Jurasza
Bydgoszcz, 85-168
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952
Poland
Pratia Onkologia Katowice
Katowice, 40519
Poland
Pratia MCM Krakow
Krakow, 30-510
Poland
Klinika Hematoonkologii i Transplantacji Szpiku,Samodzielny Publiczny Szpital Kliniczny Nr 1
Lublin, 20-081
Poland
AIDPORT Sp. z o.o.
Skórzewo, 60-185
Poland
Uniwersytecki Szpital Kliniczny Klinika
Wroclaw, 50-367
Poland
Inje Univ Busan Paik Hospital
Busan, 47392
South Korea
The Catholic University of Korea-Seoul St. Mary's Hospital
Seocho-Gu, 06591
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Spain
Hospital Clinic de Barcelona
Barcelona, 08036
Spain
Hospital Universitari Vall d'Hebron
Barcelona, 8035
Spain
Hospital Duran i Reynals
L'Hospitalet de Llobregat, 08908
Spain
Hospital Universitario Infanta Leonor-INTERNAL MED
Madrid, 28031
Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034
Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28222
Spain
Hospital Costa Del Sol
Marbella, 29600
Spain
Clinica Universitaria De Navarra
Pamplona, 31008
Spain
Hospital De Navarra
Pamplona, 31008
Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008
Spain
Hospital Universitario Virgen Macarena
Seville, 41009
Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013
Spain
Chang Bing Show Chwan Memorial Hospital
Changhua, 710
Taiwan
Chang Gung Memorial Hospital - Chiayi
Chiayi County, 61363
Taiwan
National Cheng-Kung Uni. Hosp.
Tainan, 704
Taiwan
Koo Foundation Sun Yan-Sen Cancer Center
Taipei, 112
Taiwan
Gazi University Faculty of Medicine
Ankara, 6500
Turkey (Türkiye)
9 Eylul University Hospital
Balçova, 35100
Turkey (Türkiye)
Ege Üniversitesi
Bornova, 35040
Turkey (Türkiye)
Istanbul University Istanbul Medicine Faculty
Faith, 34732
Turkey (Türkiye)
American Hospital
Istanbul, 34365
Turkey (Türkiye)
Acıbadem Maslak Hastanesi
Istanbul, 34457
Turkey (Türkiye)
Ankara University Medicine Hospital
Mamak, 06590
Turkey (Türkiye)
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED
United Kingdom
HOPE Centre
Leicester, LE1 5WW
United Kingdom
St Bartholomew's Hospital
London, EC1A 7BE
United Kingdom
Singleton Hospital
Swansea, SA2 8QA
United Kingdom