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ACTIVE NOT RECRUITING
NCT04965493
PHASE3

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.

View on ClinicalTrials.gov

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

DRUG

Pirtobrutinib

Oral

DRUG

Venetoclax

Oral

DRUG

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