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A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Sponsor: Loxo Oncology, Inc.
Summary
The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.
Official title: A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab Versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-322)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2021-09-20
Completion Date
2027-10
Last Updated
2026-01-29
Healthy Volunteers
No
Interventions
Pirtobrutinib
Oral
Venetoclax
Oral
Rituximab
Intravenous (IV)
Locations (176)
Ironwood Physicians, Ironwood Cancer and Research Centers
Chandler, Arizona, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
University of California Irvine Medical Center
Orange, California, United States
Scripps Mercy Hospital
San Diego, California, United States
Providence Medical Foundation
Santa Rosa, California, United States
Stamford Hospital
Stamford, Connecticut, 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
Mission Cancer and Blood
Des Moines, Iowa, United States
Pikeville Medical Center, Inc.
Pikeville, Kentucky, United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Research Medical Center
Kansas City, Missouri, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
The Mount Sinai Hospital
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Novant Cancer Institute Charlotte
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Regional Medical Oncology Center
Wilson, North Carolina, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The James Cancer Hospital
Columbus, Ohio, United States
Oncology Associates of Bridgeport P.C.
Eugene, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
USO - Texas Oncology - San Antonio
San Antonio, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Virginia Cancer Specialists, PC - Lee Highway
Fairfax, Virginia, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Swedish Cancer Institute; STE 1020
Seattle, Washington, United States
Northwest Cancer Specialists PC
Vancouver, Washington, United States
Royal Adelaide Hospital
Adelaide, Australia
Peninsula Private Hospital
Frankston, Australia
Royal Hobart Hospital
Hobart, Australia
The Alfred Hospital
Melbourne, Australia
St Vincent's Hospital
Melbourne, Australia
Sir Charles Gairdner Hospital
Perth, Australia
Universitair Ziekenhuis Gent
Ghent, Belgium
Groupe Jolimont
La Louvière, Belgium
CHU UCL Namur site Godinne
Yvoir, Belgium
Foothills Medical Centre
Calgary, Canada
Cross Cancer Institute
Edmonton, Canada
Jewish General Hospital
Montreal, Canada
Sunnybrook Research Institute
Toronto, Canada
BC Cancer Vancouver
Vancouver, Canada
Cancer Care Manitoba
Winnipeg, Canada
Peking University First Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
The Second Xiangya Hospital of Central South University
Changsha, China
Chongqing Cancer Hospital
Chongqing, China
Fujian Provincial Cancer Hospial
Fuzhou, China
Cancer Center of Guangzhou Medical University
Guangzhou, China
First Affiliated Hosp of College of Med, Zhejiang University
Hangzhou, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
The First Affiliated Hospital Of University Of South China
Hengyang, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, China
The First People's Hospital of Yunnan Province
Kunming, China
Jiangxi Provincial Cancer Hospital
Nanchang, China
Jiangsu Province Hospital
Nanjing, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, China
Nantong Tumor Hospital
Nantong, China
The Affiliated Hospital of Qingdao University
Qingdao, China
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai, China
Shanghai Tongren Hospital
Shanghai, China
Shengjing Hospital of China Medical University
Shenyang, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
Wuhan Union Hospital
Wuhan, China
Wu Han Tongji Hospital
Wuhan, China
Wuxi People's Hospital
Wuxi, China
Yichang Central People's Hospital
Yichang, China
Henan Provincial People's Hospital
Zhengzhou, China
Henan Cancer Hospital
Zhengzhou, China
Zhongshan City People's Hospital
Zhongshan, China
Fakultni nemocnice Brno
Brno, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
Rigshospitalet
Copenhagen, Denmark
Centre Hospitalier du Mans
Le Mans, France
Hopital Saint Eloi
Montpellier, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Morvan, France
CHU de Nantes - Hotel Dieu
Nantes, France
Hopital Saint Louis
Paris, France
Hopital de la Pitie Salpetriere
Paris, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Pole Regionalde Cancérologie(CHU de Poitiers)
Politiers, France
Hôpital de Pontchaillou
Rennes, France
Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen
Rouen, France
ICANS_Institut de Cancerologie Strasbourg Europe
Strasbourg, France
CHRU De Tours
Tours, France
Klinikum Chemnitz GmbH
Chemnitz, Germany
Universtitätsklinikum Essen AöR
Essen, Germany
Uniklinik Köln
Kerpener, Germany
München Klinik Schwabing
Koelner Platz 1, Germany
Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Hämatologie
Leipzig, Germany
Unimedizin RostockZIM III -Haemtologie
Rostock, Germany
Gemeinschaftspraxis Dres. Schöttker & Pretscher, z.Hd. Sophie Enz
Würzburg, Germany
National Institute of Oncology
Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary
Mater Misericordiae Hospital
Dublin, Ireland
University Hospital Waterford
Waterford, Ireland
Bnai Zion Medical Center
Haifa, Israel
Galilee Medical Center
Nahariya, Israel
Rabin Medical Center
Petah Tikva, Israel
Kaplan Medical Center
Rehovot, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
IRCCS - AOU di Bologna
Bologna, Italy
Azienda Ospedaliera Pugliese Ciaccio
Catanzaro, Italy
AOU Arcispedale Sant'Anna
Cona, Italy
Ospedale Santa Croce e Carle
Cuneo, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Italy
ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C
Milan, Italy
IRCCS Ospedale San Raffaele
Milan, Italy
A.O.U. di Modena
Modena, Italy
Azienda Ospedale Maggiore Della Carita
Novara, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, Italy
Policlinico Umberto I - Haematology
Rome, Italy
A.O.U. Citta' della Salute e della Scienza di Torino
Torino, Italy
Tokyo Medical and Dental University Hospital
Bunkyō City, Japan
National Cancer Center Hospital East
Chiba-Ken, Japan
University of Yamanashi Hospital
Chūō, Japan
National Cancer Center Hospital
Chūōku, Japan
University of Fukui Hospital
Fukui, Japan
Japanese Foundation for Cancer Research
Kōtō City, Japan
Kyoto Furitsu Medical University Hospital
Kyoto, Japan
Kochi Medical School Hospital
Nankoku, Japan
Okayama University Hospital
Okayama, Japan
Osaka City General Hospital
Osaka, Japan
Akershus Universitetssykehus
Nordbyhagen, Norway
St-Olavs Hospital
Trondheim, Norway
Szpitale Pomorskie Sp. z o. o.
Gdynia, Poland
Pratia Onkologia Katowice
Katowice, Poland
Pratia MCM Krakow
Krakow, Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii
Lodz, Poland
Klinika Hematoonkologii i Transplantacji Szpiku,Samodzielny Publiczny Szpital Kliniczny Nr 1
Lublin, Poland
MICS Centrum Medyczne Torun
Torun, Poland
Instytut Hermatologii I Transfuzjologii
Warsaw, Poland
Singapore General Hospital
Singapore, Singapore
Seoul National University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
MD Anderson Cancer Center
Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
Hospital Puerta De Hierro
Majadahonda, Spain
Hospital Costa Del Sol
Marbella, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Universitario Virgen Del Rocio
Seville, Spain
Hospital Universitario de Toledo
Toledo, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain
Skanes Universitetssjukhus, Hematoloaimottagningen
Lund, Sweden
Karolinska Universitetssjukhuset i Solna
Stockholm, Sweden
Ospedale Regionale Bellinzona e Valli
Bellinzona, Switzerland
Luzerner Kantonsspital
Lucerne, Switzerland
National Taiwan University Hospital
Taipei, Taiwan
Birmingham Heartlands Hospital
Birmingham, United Kingdom
St James's University Hospital
Leeds, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
Royal Marsden Hospital
London, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Derriford Hospital
Plymouth, United Kingdom