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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 (138) 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
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
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
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
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
RECRUITING
Spokane
MultiCare Health System Institute for Research and Innovation
ACTIVE_NOT_RECRUITING
Spokane
Other Locations
Argentina
Alexander Fleming
RECRUITING
Ciudad Autónoma De Buenos Aire
Hospital Privado De Comunidad
ACTIVE_NOT_RECRUITING
Mar Del Plata
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares
RECRUITING
Santa Fe
Australia
One Clinical Research
ACTIVE_NOT_RECRUITING
Nedlands
Western Health, Sunshine Hospital
ACTIVE_NOT_RECRUITING
St Albans
The Perth Blood Institute
RECRUITING
West Perth
Austria
Hanusch Krankenhaus
ACTIVE_NOT_RECRUITING
Vienna
Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
RECRUITING
Leuven
VITAZ
RECRUITING
Sint-niklaas
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
RECRUITING
Barretos
Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP
RECRUITING
Botucatu
Hemocentro Unicamp
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
RECRUITING
Curitiba
Instituto do Câncer - Hospital São Vicente de Paulo
RECRUITING
Passo Fundo
Centro Gaucho Integrado - Mae de Deus Center
RECRUITING
Porto Alegre
Hospital de Clínicas de Ribeirão Preto
RECRUITING
Ribeirão Preto
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
RECRUITING
Santo André
Centro Integrado de Pesquisa Clinica
RECRUITING
São José Do Rio Preto
Hospital BP
RECRUITING
São Paulo
Hospital da Clinicas da Faculdade de Medicina da USP
RECRUITING
São Paulo
Hospital Santa Marcelina
RECRUITING
São Paulo
Canada
Royal Victoria Hospital-Montreal
TERMINATED
Montreal
Hopital de L'Enfant Jesus
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
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
RECRUITING
Guangzhou
Hainan General Hospital
ACTIVE_NOT_RECRUITING
Haikou
First Affiliated Hosp of College of Med, Zhejiang University
RECRUITING
Hangzhou
The Second Affiliated Hospital of Zhejiang University School of Medicine
ACTIVE_NOT_RECRUITING
Hangzhou
Anhui Provincial Hospital
RECRUITING
Hefei
The Second Hospital of Anhui Medical University
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
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
RECRUITING
La Roche-sur-yon
Centre Hospitalier du Mans
RECRUITING
Le Mans
Centre Hospitalier Universitaire (Limoges) (CHU DUPUYTREN 1)
RECRUITING
Limoges
CHU de Nantes - Hotel Dieu
RECRUITING
Nantes
Centre Antoine Lacassagne
RECRUITING
Nice
Hopital de la Pitie Salpetriere
RECRUITING
Paris
Centre Hospitalier Lyon Sud
RECRUITING
Pierre-bénite
Hôpital de Pontchaillou
RECRUITING
Rennes
Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen
RECRUITING
Rouen
CHRU De Tours
RECRUITING
Tours
Germany
Gemeinschaftspraxis für Hämatologie und Onkologie (Gefos)
ACTIVE_NOT_RECRUITING
Dortmund
Onkologische Gemeinschaftspraxis / BAG
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
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
RECRUITING
Alessandria
Policlinico Sant'Orsola Malpighi
ACTIVE_NOT_RECRUITING
Bologna
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
RECRUITING
Meldola
IRCCS Ospedale San Raffaele
RECRUITING
Milan
Istituto Europeo di Oncologia
RECRUITING
Milan
Azienda Unita Sanitaria Locale di Reggio Emilia
ACTIVE_NOT_RECRUITING
Reggio Emilia
Japan
Kumamoto University Hospital
ACTIVE_NOT_RECRUITING
Kumamoto
Yamagata University Hospital
RECRUITING
Yamagata
New Zealand
Dunedin Hospital
ACTIVE_NOT_RECRUITING
Dunedin
Waikato Hospital
ACTIVE_NOT_RECRUITING
Hamilton
Momentum Clinical Research
RECRUITING
Newtown
Middlemore Clinical Trials
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
RECRUITING
Katowice
Pratia MCM Krakow
RECRUITING
Krakow
Klinika Hematoonkologii i Transplantacji Szpiku,Samodzielny Publiczny Szpital Kliniczny Nr 1
ACTIVE_NOT_RECRUITING
Lublin
AIDPORT Sp. z o.o.
RECRUITING
Skórzewo
Uniwersytecki Szpital Kliniczny Klinika
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 Clinic de Barcelona
ACTIVE_NOT_RECRUITING
Barcelona
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Duran i Reynals
ACTIVE_NOT_RECRUITING
L'hospitalet De Llobregat
Hospital Universitario Infanta Leonor-INTERNAL MED
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
ACTIVE_NOT_RECRUITING
Majadahonda
Hospital Costa Del Sol
ACTIVE_NOT_RECRUITING
Marbella
Clinica Universitaria De Navarra
RECRUITING
Pamplona
Hospital De Navarra
ACTIVE_NOT_RECRUITING
Pamplona
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Hospital Universitario Virgen Del Rocio
ACTIVE_NOT_RECRUITING
Seville
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Taiwan
Chang Bing Show Chwan Memorial Hospital
RECRUITING
Changhua
Chang Gung Memorial Hospital - Chiayi
ACTIVE_NOT_RECRUITING
Chiayi County
National Cheng-Kung Uni. Hosp.
ACTIVE_NOT_RECRUITING
Tainan
Koo Foundation Sun Yan-Sen Cancer Center
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
RECRUITING
Mamak
United Kingdom
Bristol Haematology and Oncology Centre
RECRUITING
Bristol
Castle Hill Hospital
RECRUITING
Cottingham
HOPE Centre
ACTIVE_NOT_RECRUITING
Leicester
St Bartholomew's Hospital
ACTIVE_NOT_RECRUITING
London
Singleton Hospital
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