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)

Who is this study for? Patients with chronic lymphocytic leukemia/small lymphocytic lymphoma
Status: Recruiting
Location: See all (142) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 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)

Locations
United States
California
Pacific Cancer Medical Center, Inc
RECRUITING
Anaheim
TOI Clinical Research
ACTIVE_NOT_RECRUITING
Cerritos
Stanford School of Medicine-Cancer Clinical Trials Office
RECRUITING
Palo Alto
California Cancer Associates for Research and Excellence
ACTIVE_NOT_RECRUITING
San Marcos
Florida
Florida Cancer Specialists
ACTIVE_NOT_RECRUITING
Fort Myers
Cancer Specialists of North Florida -St Augustine
ACTIVE_NOT_RECRUITING
Saint Augustine
Florida Cancer Specialists East
ACTIVE_NOT_RECRUITING
West Palm Beach
Louisiana
Hematology Oncology Clinic
ACTIVE_NOT_RECRUITING
Baton Rouge
Tulane Cancer Center Office of Clinical Research
ACTIVE_NOT_RECRUITING
New Orleans
Maryland
American Oncology Partners of Maryland, PA
RECRUITING
Bethesda
Montana
St. Vincent Frontier Cancer Center
ACTIVE_NOT_RECRUITING
Billings
Pennsylvania
Cancer Care Associates of York
ACTIVE_NOT_RECRUITING
York
South Carolina
Prisma Health Cancer Institute
ACTIVE_NOT_RECRUITING
Greenville
Tennessee
Sarah Cannon Research Institute SCRI
ACTIVE_NOT_RECRUITING
Nashville
Texas
Kelsey Research Foundation
ACTIVE_NOT_RECRUITING
Houston
Lumi Research
RECRUITING
Kingwood
Virginia
Virginia Cancer Institute
RECRUITING
Richmond
Washington
Medical Oncology Associates, PS
ACTIVE_NOT_RECRUITING
Spokane
MultiCare Health System Institute for Research and Innovation
ACTIVE_NOT_RECRUITING
Spokane
Other Locations
Argentina
Alexander Fleming
ACTIVE_NOT_RECRUITING
Ciudad Autónoma De Buenos Aire
Hospital Privado De Comunidad
ACTIVE_NOT_RECRUITING
Mar Del Plata
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares
ACTIVE_NOT_RECRUITING
Santa Fe
Australia
One Clinical Research
ACTIVE_NOT_RECRUITING
Nedlands
Western Health, Sunshine Hospital
ACTIVE_NOT_RECRUITING
St Albans
The Perth Blood Institute
ACTIVE_NOT_RECRUITING
West Perth
Austria
Hanusch Krankenhaus
ACTIVE_NOT_RECRUITING
Vienna
Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
ACTIVE_NOT_RECRUITING
Leuven
VITAZ
ACTIVE_NOT_RECRUITING
Sint-niklaas
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
ACTIVE_NOT_RECRUITING
Barretos
Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP
ACTIVE_NOT_RECRUITING
Botucatu
Hemocentro Unicamp
ACTIVE_NOT_RECRUITING
Campinas
Hospital Uopeccan - Centro de Pesquisa Clinica
ACTIVE_NOT_RECRUITING
Cascavel
Centro Integrado de Oncologia de Curitiba
ACTIVE_NOT_RECRUITING
Curitiba
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
ACTIVE_NOT_RECRUITING
Curitiba
Instituto do Câncer - Hospital São Vicente de Paulo
ACTIVE_NOT_RECRUITING
Passo Fundo
Centro Gaucho Integrado - Mae de Deus Center
ACTIVE_NOT_RECRUITING
Porto Alegre
Hospital de Clínicas de Ribeirão Preto
ACTIVE_NOT_RECRUITING
Ribeirão Preto
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
ACTIVE_NOT_RECRUITING
Santo André
Centro Integrado de Pesquisa Clinica
ACTIVE_NOT_RECRUITING
São José Do Rio Preto
Hospital BP
ACTIVE_NOT_RECRUITING
São Paulo
Hospital da Clinicas da Faculdade de Medicina da USP
ACTIVE_NOT_RECRUITING
São Paulo
Hospital Santa Marcelina
ACTIVE_NOT_RECRUITING
São Paulo
Canada
Royal Victoria Hospital-Montreal
TERMINATED
Montreal
Hopital de L'Enfant Jesus
ACTIVE_NOT_RECRUITING
Québec
Cancer Care Manitoba
ACTIVE_NOT_RECRUITING
Winnipeg
Chile
CeCim Biocinetic
ACTIVE_NOT_RECRUITING
Santiago
Inmunocel
ACTIVE_NOT_RECRUITING
Santiago
Sociedad de Investigaciones Médicas Limitada
ACTIVE_NOT_RECRUITING
Temuco
Centro de Investigaciones Clínicas Viña del Mar (CIC)
ACTIVE_NOT_RECRUITING
Viña Del Mar
China
Hunan Cancer Hospital
ACTIVE_NOT_RECRUITING
Changsha
The Second Xiangya Hospital of Central South University
ACTIVE_NOT_RECRUITING
Changsha
Southern Medical University Nanfang Hospital
ACTIVE_NOT_RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
ACTIVE_NOT_RECRUITING
Guangzhou
Hainan General Hospital
ACTIVE_NOT_RECRUITING
Haikou
First Affiliated Hosp of College of Med, Zhejiang University
ACTIVE_NOT_RECRUITING
Hangzhou
The Second Affiliated Hospital of Zhejiang University School of Medicine
ACTIVE_NOT_RECRUITING
Hangzhou
Anhui Provincial Hospital
ACTIVE_NOT_RECRUITING
Hefei
The Second Hospital of Anhui Medical University
ACTIVE_NOT_RECRUITING
Hefei
Jiangxi Provincial Cancer Hospital
ACTIVE_NOT_RECRUITING
Nanchang
Guangxi Medical University Affiliated Tumor Hospital
ACTIVE_NOT_RECRUITING
Nanning
Fudan University Shanghai Cancer Center
ACTIVE_NOT_RECRUITING
Shanghai
Blood Institute of the Chinese Academy of Medical science
ACTIVE_NOT_RECRUITING
Tianjin
Tianjin Medical University General Hospital
ACTIVE_NOT_RECRUITING
Tianjin
Affiliated Cancer Hospital of Xinjiang Medical University
ACTIVE_NOT_RECRUITING
Ürümqi
Union Hospital Tongji Medical College Huazhong University of Science and Technology
ACTIVE_NOT_RECRUITING
Wuhan
Wu Han Tongji Hospital
ACTIVE_NOT_RECRUITING
Wuhan
The Fourth Affiliated Hospital Zhejiang University School of Medicine
ACTIVE_NOT_RECRUITING
Yiwu
France
CHD Vendee
ACTIVE_NOT_RECRUITING
La Roche-sur-yon
Centre Hospitalier du Mans
ACTIVE_NOT_RECRUITING
Le Mans
Centre Hospitalier Universitaire (Limoges) (CHU DUPUYTREN 1)
ACTIVE_NOT_RECRUITING
Limoges
CHU de Nantes - Hotel Dieu
ACTIVE_NOT_RECRUITING
Nantes
Centre Antoine Lacassagne
ACTIVE_NOT_RECRUITING
Nice
Hopital de la Pitie Salpetriere
ACTIVE_NOT_RECRUITING
Paris
Centre Hospitalier Lyon Sud
ACTIVE_NOT_RECRUITING
Pierre-bénite
Hôpital de Pontchaillou
ACTIVE_NOT_RECRUITING
Rennes
Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen
ACTIVE_NOT_RECRUITING
Rouen
CHRU De Tours
ACTIVE_NOT_RECRUITING
Tours
Germany
Gemeinschaftspraxis für Hämatologie und Onkologie (Gefos)
ACTIVE_NOT_RECRUITING
Dortmund
Onkologische Gemeinschaftspraxis / BAG
ACTIVE_NOT_RECRUITING
Dresden
Universitaetsklinikum Carl Gustav Carus an der TU Dresden, Medizinische Klinik und Poliklinik 1
ACTIVE_NOT_RECRUITING
Dresden
Universitätsklinikum Ulm
ACTIVE_NOT_RECRUITING
Ulm
Hungary
Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
ACTIVE_NOT_RECRUITING
Debrecen
Markusovszky Egyetemi Oktatokorhaz
ACTIVE_NOT_RECRUITING
Szombathely
Israel
Hadassah Medical Center
ACTIVE_NOT_RECRUITING
Jerusalem
Tel Aviv Sourasky Medical Center
ACTIVE_NOT_RECRUITING
Tel Aviv
Italy
Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
ACTIVE_NOT_RECRUITING
Alessandria
Policlinico Sant'Orsola Malpighi
ACTIVE_NOT_RECRUITING
Bologna
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
ACTIVE_NOT_RECRUITING
Meldola
IRCCS Ospedale San Raffaele
ACTIVE_NOT_RECRUITING
Milan
Istituto Europeo di Oncologia
ACTIVE_NOT_RECRUITING
Milan
Azienda Unita Sanitaria Locale di Reggio Emilia
ACTIVE_NOT_RECRUITING
Reggio Emilia
A.O.U. Citta' della Salute e della Scienza di Torino
RECRUITING
Torino
Japan
Kumamoto University Hospital
ACTIVE_NOT_RECRUITING
Kumamoto
Yamagata University Hospital
ACTIVE_NOT_RECRUITING
Yamagata
New Zealand
Dunedin Hospital
ACTIVE_NOT_RECRUITING
Dunedin
Waikato Hospital
ACTIVE_NOT_RECRUITING
Hamilton
Momentum Clinical Research
ACTIVE_NOT_RECRUITING
Newtown
Middlemore Clinical Trials
ACTIVE_NOT_RECRUITING
Papatoetoe
Poland
KO-MED Centra Kliniczne
ACTIVE_NOT_RECRUITING
Biała Podlaska
Szpital Uniwersytecki nr 1 im. Antoniego Jurasza
ACTIVE_NOT_RECRUITING
Bydgoszcz
Uniwersyteckie Centrum Kliniczne
ACTIVE_NOT_RECRUITING
Gdansk
Pratia Onkologia Katowice
ACTIVE_NOT_RECRUITING
Katowice
Pratia MCM Krakow
ACTIVE_NOT_RECRUITING
Krakow
Klinika Hematoonkologii i Transplantacji Szpiku,Samodzielny Publiczny Szpital Kliniczny Nr 1
ACTIVE_NOT_RECRUITING
Lublin
AIDPORT Sp. z o.o.
ACTIVE_NOT_RECRUITING
Skórzewo
Uniwersytecki Szpital Kliniczny Klinika
ACTIVE_NOT_RECRUITING
Wroclaw
Republic of Korea
Inje Univ Busan Paik Hospital
RECRUITING
Busan
The Catholic University of Korea-Seoul St. Mary's Hospital
ACTIVE_NOT_RECRUITING
Seocho-gu
Samsung Medical Center
ACTIVE_NOT_RECRUITING
Seoul
Seoul National University Hospital
ACTIVE_NOT_RECRUITING
Seoul
Spain
Hospital Germans Trias i Pujol
RECRUITING
Badalona
Hospital Clinic de Barcelona
ACTIVE_NOT_RECRUITING
Barcelona
Hospital de la Santa Creu i Sant Pau
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
ACTIVE_NOT_RECRUITING
Barcelona
Institut Català d'Oncologia de Girona (ICO Girona)
RECRUITING
Girona
Hospital Duran i Reynals
ACTIVE_NOT_RECRUITING
L'hospitalet De Llobregat
Hospital De Gran Canaria Dr. Negrin
RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario Infanta Leonor-INTERNAL MED
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
ACTIVE_NOT_RECRUITING
Majadahonda
Hospital Costa Del Sol
ACTIVE_NOT_RECRUITING
Marbella
Clinica Universitaria De Navarra
ACTIVE_NOT_RECRUITING
Pamplona
Hospital De Navarra
ACTIVE_NOT_RECRUITING
Pamplona
Hospital Universitario Marqués de Valdecilla
ACTIVE_NOT_RECRUITING
Santander
Hospital Universitario Virgen Del Rocio
ACTIVE_NOT_RECRUITING
Seville
Hospital Universitario Virgen Macarena
ACTIVE_NOT_RECRUITING
Seville
Taiwan
Chang Bing Show Chwan Memorial Hospital
ACTIVE_NOT_RECRUITING
Changhua
Chang Gung Memorial Hospital - Chiayi
ACTIVE_NOT_RECRUITING
Chiayi County
National Cheng-Kung Uni. Hosp.
ACTIVE_NOT_RECRUITING
Tainan City
Koo Foundation Sun Yan-Sen Cancer Center
ACTIVE_NOT_RECRUITING
Taipei
Turkey
Gazi University Faculty of Medicine
ACTIVE_NOT_RECRUITING
Ankara
9 Eylul University Hospital
ACTIVE_NOT_RECRUITING
Balçova
Ege Üniversitesi
ACTIVE_NOT_RECRUITING
Bornova
Istanbul University Istanbul Medicine Faculty
ACTIVE_NOT_RECRUITING
Faith
Acıbadem Maslak Hastanesi
COMPLETED
Istanbul
American Hospital
ACTIVE_NOT_RECRUITING
Istanbul
Ankara University Medicine Hospital
ACTIVE_NOT_RECRUITING
Mamak
United Kingdom
Bristol Haematology and Oncology Centre
ACTIVE_NOT_RECRUITING
Bristol
Castle Hill Hospital
RECRUITING
Cottingham
HOPE Centre
ACTIVE_NOT_RECRUITING
Leicester
St Bartholomew's Hospital
ACTIVE_NOT_RECRUITING
London
Singleton Hospital
ACTIVE_NOT_RECRUITING
Swansea
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2022-07-22
Estimated Completion Date: 2028-01
Participants
Target number of participants: 662
Treatments
Experimental: Pirtobrutinib Part 1
Participants will receive pirtobrutinib orally.
Active_comparator: Ibrutinib
Participants will receive ibrutinib orally.
Experimental: Pirtobrutinib Part 2
Participants will receive pirtobrutinib orally.
Sponsors
Leads: Loxo Oncology, Inc.

This content was sourced from clinicaltrials.gov

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