AzTrials
AzTrials

Chronic Lymphocytic LeukemiaPhase 3BRUIN-CLL-314NCT05254743

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

A Phase 3 study testing Pirtobrutinib and Ibrutinib in people with Chronic Lymphocytic Leukemia and Leukemia, Lymphocytic, run by Loxo Oncology, Inc. at 143 sites in 23 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pirtobrutinib and Ibrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
737 participants
Where
143 sitesin 23 countries
Study dates
22 Jul 2022to Jan 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment
  • Known or suspected central nervous system (CNS) involvement
  • A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease
  • Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])
  • Significant cardiovascular disease including ejection fraction < 40% and any grade ongoing atrial fibrillation or atrial flutter
  • Hepatitis B or hepatitis C testing indicating active/ongoing infection, based on Screening laboratory tests
Show all 19Show fewer
  • Active cytomegalovirus (CMV) infection
  • Active uncontrolled systemic bacterial, viral, or fungal infection
  • Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
  • Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments
  • Ongoing inflammatory bowel disease
  • Previous treatment for CLL/SLL - Part 1: Treatment-naïve and previously treated, except prior exposure to BTK inhibitor (covalent or noncovalent).
  • Part 2: participants must be treatment naïve
  • Concurrent use of investigational agent or anticancer therapy except hormonal therapy
  • Participants requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
  • Use of > 20 mg prednisone daily or equivalent dose of steroid at the time of first dose of study drug
  • Vaccination with a live vaccine within 28 days prior to randomization
  • Participants receiving chronic therapy with a strong cytochrome P450 (CYP)3A inhibitor (except posaconazole and voriconazole) which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment
  • Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib

Trial locations and contacts

143 sites in 23 countries. Contact the study team or a site near you to ask about taking part.

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact

1-317-615-4559

LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact contact

clinical_inquiry_hub@lilly.com

143 sites in 23 countries

United States19 sites, 12 recruiting

  • Pacific Cancer Medical Center, Inc

    Anaheim, California, 92801

    714-999-1465

    Veena Charu

    Recruiting

  • Hematology Oncology Clinic

    Baton Rouge, Louisiana, 70809

    Active, not recruiting

  • American Oncology Partners of Maryland, PA

    Bethesda, Maryland, 20817

    301-571-0019

    Victor Priego

    Recruiting

  • St. Vincent Frontier Cancer Center

    Billings, Montana, 59102

    406-238-6685

    Patrick Cobb

    Recruiting

  • TOI Clinical Research

    Cerritos, California, 90703

    562-693-4477

    MICHAEL DEL ROSARIO

    Recruiting

  • Florida Cancer Specialists

    Fort Myers, Florida, 33916-2233

    727-216-1143

    Jennifer Cultrera

    Recruiting

  • Prisma Health Cancer Institute

    Greenville, South Carolina, 29605

    Active, not recruiting

  • Kelsey Research Foundation

    Houston, Texas, 77025

    Active, not recruiting

  • Lumi Research

    Kingwood, Texas, 77339

    (832) 553-3661 ext. 122

    David Nguyen

    Recruiting

  • Sarah Cannon Research Institute SCRI

    Nashville, Tennessee, 37203

    423-622-6212

    Bertrand Anz III

    Recruiting

  • Tulane Cancer Center Office of Clinical Research

    New Orleans, Louisiana, 70112

    Active, not recruiting

  • Stanford School of Medicine-Cancer Clinical Trials Office

    Palo Alto, California, 94305

    650-498-6000

    Bita Fakhri

    Recruiting

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

    804-287-3000

    Yuvraj Choudhary

    Recruiting

  • Cancer Specialists of North Florida -St Augustine

    Saint Augustine, Florida, 32086

    904-538-4488

    Ayed Ayed

    Recruiting

  • California Cancer Associates for Research and Excellence

    San Marcos, California, 92069

    Active, not recruiting

  • Medical Oncology Associates, PS

    Spokane, Washington, 99208

    509-462-2273

    Arvind Chaudhry

    Recruiting

  • MultiCare Health System Institute for Research and Innovation

    Spokane, Washington, 99218

    Active, not recruiting

  • Florida Cancer Specialists East

    West Palm Beach, Florida, 33401

    561-366-4100

    Shachar Peles

    Recruiting

  • Cancer Care Associates Of York

    York, Pennsylvania, 17403

    Active, not recruiting

Other trials in United States

China18 sites, 7 recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, 410011

    Active, not recruiting

  • Hunan Cancer Hospital

    Changsha, 410013

    Active, not recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, 510060

    +86 13798032244

    He Huang

    Recruiting

  • Southern Medical University Nanfang Hospital

    Guangzhou, 510515

    +8613802426709

    Xutao Guo

    Recruiting

  • Hainan General Hospital

    Haikou, 570311

    Active, not recruiting

  • First Affiliated Hosp of College of Med, Zhejiang University

    Hangzhou, 310003

    86 13505716779

    Jie Jin

    Recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, 310009

    Active, not recruiting

  • Anhui Provincial Hospital

    Hefei, 230001

    8613856007984

    Xingbing Wang

    Recruiting

  • The Second Hospital of Anhui Medical University

    Hefei, 231200

    +86 13855147434

    Zhai Zhimin

    Recruiting

  • Jiangxi Provincial Cancer Hospital

    Nanchang, 330029

    Active, not recruiting

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, 530021

    +86 13507711671

    Hong Cen

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

    13651680209

    Junning Cao

    Recruiting

  • Blood Institute of the Chinese Academy of Medical science

    Tianjin, 300020

    Active, not recruiting

  • Tianjin Medical University General Hospital

    Tianjin, 300052

    Active, not recruiting

  • Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, 830000

    Active, not recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430022

    Active, not recruiting

  • Wu Han Tongji Hospital

    Wuhan, 430030

    Active, not recruiting

  • The Fourth Affiliated Hospital Zhejiang University School of Medicine

    Yiwu, 322000

    Active, not recruiting

Other trials in China

Brazil14 sites, 13 recruiting

  • Fundação Pio XII - Hospital de Câncer de Barretos

    Barretos, 14784400

    Nelson Siqueira de Castro

    Recruiting

  • Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP

    Botucatu, 18618-687

    +55 14 3880-1663

    Rafael Dezen Gaiolla

    Recruiting

  • Hemocentro Unicamp

    Campinas, 13083-878

    55 19 3521-8630

    Fernando Vieira Pericole de Souza

    Recruiting

  • Hospital Uopeccan - Centro de Pesquisa Clinica

    Cascavel, 85806-300

    +55 (45) 9 9135 1056

    Gabriela Almeida Garcia

    Recruiting

  • Centro Integrado de Oncologia de Curitiba

    Curitiba, 80810050

    Active, not recruiting

  • Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

    Curitiba, 81520060

    (41) 9998-46033

    João Samuel de Holanda Farias

    Recruiting

  • Instituto do Câncer - Hospital São Vicente de Paulo

    Passo Fundo, 99010090

    555421034130

    Moema Nene Santos

    Recruiting

  • Centro Gaucho Integrado - Mae de Deus Center

    Porto Alegre, 90110270

    +55 51 33072943

    Marcelo Capra

    Recruiting

  • Hospital de Clínicas de Ribeirão Preto

    Ribeirão Preto, 14051-140

    16 98112-6986

    Diego Villa Clé

    Recruiting

  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

    Santo André, 09060-650

    +55.11.4993-5491

    Debora Rodrigues Bonito

    Recruiting

  • Centro Integrado de Pesquisa Clinica

    São José do Rio Preto, 15090-000

    +55 (17)3201-5000

    Carlos Eduardo Miguel

    Recruiting

  • Hospital BP

    São Paulo, 01321-001

    551135056675

    Danielle Leão Cordeiro de Farias

    Recruiting

  • Hospital da Clinicas da Faculdade de Medicina da USP

    São Paulo, 05403-000

    +55 11 4573-7631

    Raphael Costa Bandeira de Melo

    Recruiting

  • Hospital Santa Marcelina

    São Paulo, 08270-120

    55 11 22173766

    Patricia de Paulo Giacon

    Recruiting

Other trials in Brazil

Spain13 sites, 11 recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

    +34 93 556 5647

    Miguel Arguello de Tomas

    Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Active, not recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 8035

    +34 932746000

    Francesc Bosch Albareda

    Recruiting

  • Hospital Duran i Reynals

    L'Hospitalet de Llobregat, 08908

    Active, not recruiting

  • Hospital Universitario Infanta Leonor-INTERNAL MED

    Madrid, 28031

    +34619249275

    Jose Hernandez Rivas

    Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

    +34 91 3368637

    Javier Lopez Jimenez

    Recruiting

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222

    +34 91 191 68 80

    Garcia Vela Jose Antonio

    Recruiting

  • Hospital Costa Del Sol

    Marbella, 29600

    +34 (951) 976-957

    Angeles Medina Perez

    Recruiting

  • Clinica Universitaria De Navarra

    Pamplona, 31008

    913531920 ext. 7511

    Rocio Figueroa Mora

    Recruiting

  • Hospital De Navarra

    Pamplona, 31008

    +34848428428

    Jose Maria Arguiñano Perez

    Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

    942 31 52 75

    Lucrecia Yañez San Segundo

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    +34619848594

    Alicia Rodriguez Fernandez

    Recruiting

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

    +34955013277

    Fatima de la Cruz Vicente

    Recruiting

Other trials in Spain

France10 sites, 10 recruiting

  • CHD Vendee

    La Roche-sur-Yon, 85000

    +33251446173

    Jessie Bourcier

    Recruiting

  • Centre Hospitalier du Mans

    Le Mans, 72000

    +33 2.43.43.29.59

    Kamel Laribi

    Recruiting

  • Centre Hospitalier Universitaire (Limoges) (CHU DUPUYTREN 1)

    Limoges, 87042

    +33(0)555 05 88 22

    Nataliya Dmutruk

    Recruiting

  • CHU de Nantes - Hotel Dieu

    Nantes, 44093

    Anne Lok

    Recruiting

  • Centre Antoine Lacassagne

    Nice, 06189

    33 (0)4 92 03 10 35

    Luca INCHIAPPA

    Recruiting

  • Hopital de la Pitie Salpetriere

    Paris, 75651

    +33 1 42 16 15 96

    Damien Roos-Weil

    Recruiting

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

    +33 4 78 86 43 07

    Emmanuelle Ferrant

    Recruiting

  • Hôpital de Pontchaillou

    Rennes, 35033

    +33 299 28 4291

    Sophie De Guibert

    Recruiting

  • Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen

    Rouen, 76038

    + 33 2 32 08 22 23

    Stephane Lepretre

    Recruiting

  • CHRU De Tours

    Tours, 37044

    +33 2 47 47 37 12

    Caroline Dartigeas

    Recruiting

Other trials in France

Poland8 sites, 6 recruiting

  • KO-MED Centra Kliniczne

    Biała Podlaska, 21500

    Active, not recruiting

  • Szpital Uniwersytecki nr 1 im. Antoniego Jurasza

    Bydgoszcz, 85-168

    +48696476575

    Marta Sobas

    Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

    48585844357

    Monika Szarejko

    Recruiting

  • Pratia Onkologia Katowice

    Katowice, 40519

    +48 600 388 282

    Sabastian Grosicki

    Recruiting

  • Pratia MCM Krakow

    Krakow, 30-510

    +48451077231

    Wojciech Jurczak

    Recruiting

  • Klinika Hematoonkologii i Transplantacji Szpiku,Samodzielny Publiczny Szpital Kliniczny Nr 1

    Lublin, 20-081

    Active, not recruiting

  • AIDPORT Sp. z o.o.

    Skórzewo, 60-185

    Michal Kwiatek

    Recruiting

  • Uniwersytecki Szpital Kliniczny Klinika

    Wroclaw, 50-367

    +48 784 25 76

    Tomasz Wrobel

    Recruiting

Other trials in Poland

Turkey (Türkiye)7 sites, 3 recruiting

  • Gazi University Faculty of Medicine

    Ankara, 6500

    Active, not recruiting

  • 9 Eylul University Hospital

    Balçova, 35100

    Active, not recruiting

  • Ege Üniversitesi

    Bornova, 35040

    Active, not recruiting

  • Istanbul University Istanbul Medicine Faculty

    Faith, 34732

    +90 533 575 90 96

    Mustafa Nuri Yenerel

    Recruiting

  • American Hospital

    Istanbul, 34365

    +90 532 256 6160

    Burhan Ferhanoglu

    Recruiting

  • Acıbadem Maslak Hastanesi

    Istanbul, 34457

    Completed

  • Ankara University Medicine Hospital

    Mamak, 06590

    90 505 502 50 50

    Muhit Özcan

    Recruiting

Other trials in Turkey (Türkiye)

Czechia6 sites, 6 recruiting

  • Fakultni nemocnice Brno

    Brno, 62500

    (+420) 532 233 642

    Anna Panovska

    Recruiting

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

    +420 777 846 836

    Martin Simkovic

    Recruiting

  • Fakultni Nemocnice Ostrava

    Ostrava, 708 52

    (+420) 597 372 749

    Jana Mihalyova

    Recruiting

  • Fakultni Nemocnice Plzen

    Pilsen, 305 99

    (+420) 377 103 722

    Daniel Lysak

    Recruiting

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 10034

    (+420) 267 163 530

    Jan Novak

    Recruiting

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12808

    (+420)224962527

    Marek Trneny

    Recruiting

Other trials in Czechia

Italy6 sites, 4 recruiting

  • Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo

    Alessandria, 15100

    39 0131 206440

    Gioacchino Catania

    Recruiting

  • Policlinico Sant'Orsola Malpighi

    Bologna, 40138

    Active, not recruiting

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014

    +390543739100

    Gerardo Musuraca

    Recruiting

  • IRCCS Ospedale San Raffaele

    Milan, 20132

    39.02.26434797

    Paolo Ghia

    Recruiting

  • Istituto Europeo di Oncologia

    Milan, 20141

    +39 02 57489403

    Enrico Derenzini

    Recruiting

  • Azienda Unita Sanitaria Locale di Reggio Emilia

    Reggio Emilia, 42122

    Active, not recruiting

Other trials in Italy

Chile4 sites, 1 recruiting

  • Inmunocel

    Santiago, 7580206

    Active, not recruiting

  • CeCim Biocinetic

    Santiago, 8320000

    Active, not recruiting

  • Sociedad de Investigaciones Médicas Limitada

    Temuco, 4780000

    +56974316500

    Eduardo Yañez

    Recruiting

  • Centro de Investigaciones Clínicas Viña del Mar (CIC)

    Viña del Mar, 2520000

    Active, not recruiting

Other trials in Chile

Germany4 sites, 1 recruiting

  • Gemeinschaftspraxis für Hämatologie und Onkologie (Gefos)

    Dortmund, 44309

    Active, not recruiting

  • Onkologische Gemeinschaftspraxis / BAG

    Dresden, 01307

    +4935144950701

    Lutz Jacobasch

    Recruiting

  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden, Medizinische Klinik und Poliklinik 1

    Dresden, 01307

    Active, not recruiting

  • Universitätsklinikum Ulm

    Ulm, 89075

    Active, not recruiting

Other trials in Germany

New Zealand4 sites, 2 recruiting

  • Dunedin Hospital

    Dunedin, 9016

    Active, not recruiting

  • Waikato Hospital

    Hamilton, 3204

    Active, not recruiting

  • Momentum Clinical Research

    Newtown, 6242

    Robert Weinkove

    Recruiting

  • Middlemore Clinical Trials

    Papatoetoe, 2025

    + 64 212 618 734

    James Liang

    Recruiting

Other trials in New Zealand

South Korea4 sites, 3 recruiting

  • Inje Univ Busan Paik Hospital

    Busan, 47392

    +82-51-890-6407

    Won Lee

    Recruiting

  • The Catholic University of Korea-Seoul St. Mary's Hospital

    Seocho-Gu, 06591

    02-2228-6056

    Ki-Seong Eom

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    82 2 2072 3079

    Ja Min Byun

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Active, not recruiting

Other trials in South Korea

Taiwan4 sites, 3 recruiting

  • Chang Bing Show Chwan Memorial Hospital

    Changhua, 710

    +886-4-7813-888#70290

    Cheng-Shyong Chang

    Recruiting

  • Chang Gung Memorial Hospital - Chiayi

    Chiayi County, 61363

    +886-5-3621000 ext:2106

    Yu-Ying Wu

    Recruiting

  • National Cheng-Kung Uni. Hosp.

    Tainan, 704

    Active, not recruiting

  • Koo Foundation Sun Yan-Sen Cancer Center

    Taipei, 112

    +886-2-28970011

    Tran-Der Tan

    Recruiting

Other trials in Taiwan

United Kingdom4 sites, 2 recruiting

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED

    0117 3421121

    Sanne Lugthart

    Recruiting

  • HOPE Centre

    Leicester, LE1 5WW

    Active, not recruiting

  • St Bartholomew's Hospital

    London, EC1A 7BE

    Active, not recruiting

  • Singleton Hospital

    Swansea, SA2 8QA

    01792 285301

    Unmesh Mohite

    Recruiting

Other trials in United Kingdom

Argentina3 sites, 2 recruiting

  • Alexander Fleming

    Ciudad Autónoma de Buenos Aire, C1426ANZ

    +54 9 11 4051-0781

    María Del Rosario Custidiano

    Recruiting

  • Hospital Privado De Comunidad

    Mar del Plata, 7600

    Active, not recruiting

  • Clínica de Nefrología, Urología y Enfermedades Cardiovasculares

    Santa Fe, 3000

    +54 (342) 4055449

    Manuela Moreira Rodriguez

    Recruiting

Other trials in Argentina

Australia3 sites, 1 recruiting

  • One Clinical Research

    Nedlands, 6009

    Active, not recruiting

  • Western Health, Sunshine Hospital

    St Albans, 3021

    Active, not recruiting

  • The Perth Blood Institute

    West Perth, 6005

    Ross Baker

    Recruiting

Other trials in Australia

Canada3 sites, 1 recruiting

  • Royal Victoria Hospital-Montreal

    Montreal, H3A 1A1

    Terminated

  • Hopital de L'Enfant Jesus

    Québec, G1J 1Z4

    418-525-4444 ext. 0

    Robert Delage

    Recruiting

  • Cancer Care Manitoba

    Winnipeg, R3E 0V9

    Active, not recruiting

Other trials in Canada

Belgium2 sites, 2 recruiting

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, 3000

    +3216346880

    Ann Janssens

    Recruiting

  • VITAZ

    Sint-Niklaas, B-9100

    +32 3 760 2985

    Vanessa Van Hende

    Recruiting

Other trials in Belgium

Hungary2 sites, 1 recruiting

  • Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum

    Debrecen, 4004

    3652255196

    Arpad Illes

    Recruiting

  • Markusovszky Egyetemi Oktatokorhaz

    Szombathely, 9700

    Active, not recruiting

Other trials in Hungary

Israel2 sites, 1 recruiting

  • Hadassah Medical Center

    Jerusalem, 9112001

    050-8573679

    Neta Goldschmidt

    Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

    Active, not recruiting

Other trials in Israel

Japan2 sites, 1 recruiting

  • Kumamoto University Hospital

    Kumamoto, 860-8556

    Active, not recruiting

  • Yamagata University Hospital

    Yamagata, 990-9585

    81120023812

    Hisayuki Yokoyama

    Recruiting

Other trials in Japan

Austria1 site

  • Hanusch Krankenhaus

    Vienna, 1140

    Active, not recruiting

Other trials in Austria

About this study

Official title: 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)

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.

Being tested
Pirtobrutinib, Ibrutinib
Keywords
BTKi, Hematologic Disease, Lymphoma, non-Hodgkin's, Lymphoma, B-cell
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Lymphoid, Leukemia, B-Cell, Hematologic Diseases, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PirtobrutinibDrug

    Also called LOXO-305, LY3527727

    Administered orally.

  • IbrutinibDrug

    Administered orally.

Study groups in NCT05254743
Study groupRoleWhat they receive
Pirtobrutinib Part 1ExperimentalParticipants will receive pirtobrutinib orally.
Receives: Drug: Pirtobrutinib
Ibrutinib Part 1Active comparatorParticipants will receive ibrutinib orally.
Receives: Drug: Ibrutinib
Pirtobrutinib Part 2ExperimentalParticipants will receive pirtobrutinib orally.
Receives: Drug: Pirtobrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (Cri), Nodular Partial Remission (nPR) or Partial Response (PR): Overall Response Rate (ORR) Part 1

    ORR as assessed by independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria

    Measured: Baseline to best overall response the best response recorded from Cycle 1 Day 1 until data cutoff date, PD, or start of new anticancer treatment, whichever is the earliest] (approximately 3 years and 5 months)

  2. Percentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (CRi), Nodular Partial Remission (nPR) or Partial Response (PR): Overall Response Rate (ORR) Part 2

    ORR as assessed by independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria

    Measured: Baseline to best overall response the best response recorded from Cycle 1 Day 1 until data cutoff date, PD, or start of new anticancer treatment, whichever is the earliest (Approximately 2 years and 3 months)

Secondary outcomes (9)

  1. IRC-assessed Progression-Free Survival (PFS)

    PFS by IRC per iwCLL 2018 criteria

    Measured: Randomization to PD (per iwCLL 2018 criteria) or death from any cause (approximately 5 years 8 months)

  2. Investigator assessed Progression-Free Survival (PFS)

    PFS by Investigator per iwCLL 2018 criteria

    Measured: Randomization to PD (per iwCLL 2018 criteria) or death from any cause (approximately 5 years 8 months)

  3. Event-Free Survival (EFS)

    EFS by IRC per iwCLL 2018 criteria

    Measured: Randomization to first occurrence of treatment discontinuation due to adverse event/toxicity, treatment-emergent atrial fibrillation or atrial flutter of any grade, progressive disease (PD) or death (approximately 4 years)

  4. Duration of Response (DOR)

    DOR by IRC and Investigator by iwCLL 2018 Criteria.

    Measured: Time from the date of the first documented response of CR, CRi, nPR or PR to the earlier of documentation of definitive PD (per iwCLL 2018 criteria) or death from any cause (approximately 2 years)

  5. Overall Survival (OS)

    OS

    Measured: Randomization to death from any cause (approximately 6 years)

  6. Time to Next Treatment (TTNT)

    TTNT

    Measured: Randomization to initiation of the next systemic anticancer therapy for CLL/SLL or death from any cause, whichever occurs first (approximately 6 years)

  7. Time to Worsening (TTW) of CLL/SLL Related Symptoms

    Using symptom questions identified from the EORTC item library. The range of raw scores for these items could be from 0 to 52 with highest score being worse symptoms.

    Measured: Randomization to time to worsening symptoms (approximately 4 years)

  8. Comparative Tolerability

    Comparative Tolerability measured by proportion of time with high side-effect burden

    Measured: From Baseline to Treatment Discontinuation for Any Reason (approximately 4 years)

  9. Percentage of Participants Achieving DOR Part 2

    DOR as assessed by IRC and Investigator defined as the time from the date of the first documented response of CR, CRi, nPR, or PR to the earlier of the documentation of definitive PD per iwCLL 2018 criteria or death from any cause.

    Measured: Time from the date of the first documented response of CR, CRi, nPR, or PR to the earlier of the documentation of definitive PD or death from any cause] (Approximately 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2022
  2. Study start22 Jul 2022
  3. Primary completionOct 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
737 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05254743
Sponsor's protocol ID
18281
Other IDs
J2N-OX-JZNU, LOXO-BTK-20030, 2023-507699-38-00, 2023
Acronym
BRUIN-CLL-314
Status last verified
Aug 2026
First submitted
15 Feb 2022
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Expanded access
Available

Publications

  • Eyre TA, Hess LM, Masoudi E, Jen MH, Abhyankar S, Graham-Clarke PL, Bhandari NR, Maguire P, Winfree KB, Tracey M, Taipale KL, Davids MS. Efficacy of Pirtobrutinib Monotherapy in Treatment-Naive Chronic Lymphocytic Leukemia: A Bayesian Network Meta-Analysis of Randomized Controlled Trials. Cancers (Basel). 2026 Feb 18;18(4):660. doi: 10.3390/cancers18040660.

    PubMed 41749915

  • Woyach JA, Qiu L, Grosicki S, Wrobel T, Capra M, Czyz J, Yi S, Eom KS, Panovska A, Jurczak W, Laribi K, Jacobasch L, Baker R, Agajanian R, Berkovits A, Ozcan M, Lepretre S, Coombs CC, Cramer P, Lewis KL, Hill M, Bao K, Bian Y, De Batista Ribeiro SR, Bhandari NR, Ruppert AS, Leow CC, Wierda WG. Pirtobrutinib Versus Ibrutinib in Treatment-Naive and Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. J Clin Oncol. 2026 Feb 20;44(6):476-485. doi: 10.1200/JCO-25-02477. Epub 2025 Dec 7.

    PubMed 41353787

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pirtobrutinib and Ibrutinib in people with Chronic Lymphocytic Leukemia and Leukemia, Lymphocytic, run by Loxo Oncology, Inc. at 143 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 143 sites in United States, China, Brazil, Spain, France and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (Cri), Nodular Partial Remission (nPR) or Partial Response (PR): Overall Response Rate (ORR) Part 1 (time frame: Baseline to best overall response the best response recorded from Cycle 1 Day 1 until data cutoff date, PD, or start of new anticancer treatment, whichever is the earliest] (approximately 3 years and 5 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05254743, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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