RecruitingPhase 3NCT05254743

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

A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)

Sponsor

Loxo Oncology, Inc.

Enrollment

662 participants

Start Date

Jul 22, 2022

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Leukemia, B-cell Leukemia, Lymphocytic

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two BTK inhibitors — pirtobrutinib and ibrutinib — for treating chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), two closely related slow-growing blood cancers. Pirtobrutinib is a newer drug that may work better in some patients, particularly those with high-risk genetic features like the 17p deletion. **You may be eligible if...** - You have confirmed CLL or SLL that now requires treatment - You are in reasonably good physical condition (ECOG 0-2) - Your blood counts and kidney function are at adequate levels - Part 2 participants must have a 17p deletion (a specific high-risk genetic change) confirmed by FISH testing **You may NOT be eligible if...** - Your disease has transformed into a more aggressive form (such as diffuse large B-cell lymphoma) - Your cancer has spread to the central nervous system - You have active hepatitis B or significant uncontrolled heart disease - You have active autoimmune blood cell destruction - You have significant neurological, psychiatric, or immune conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPirtobrutinib

Administered orally.

DRUGIbrutinib

Administered orally.

Locations(144)

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

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 de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Duran i Reynals

L'Hospitalet de Llobregat, 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

View Full Details on ClinicalTrials.gov

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NCT05254743

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