A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN-CLL-314)

June 5, 2026 updated by: Loxo Oncology, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

737

Phase

  • Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Argentina
      • Ciudad Autónoma de Buenos Aire, Argentina, C1426ANZ
        • Recruiting
        • Alexander Fleming
        • Contact:
          • Phone Number: +54 9 11 4051-0781
        • Principal Investigator:
          • María Del Rosario Custidiano
      • Mar del Plata, Argentina, 7600
        • Active, not recruiting
        • Hospital Privado De Comunidad
      • Santa Fe, Argentina, 3000
        • Recruiting
        • Clínica de Nefrología, Urología y Enfermedades Cardiovasculares
        • Contact:
          • Phone Number: +54 (342) 4055449
        • Principal Investigator:
          • Manuela Moreira Rodriguez
  • Australia
      • Nedlands, Australia, 6009
        • Active, not recruiting
        • One Clinical Research
      • St Albans, Australia, 3021
        • Active, not recruiting
        • Western Health, Sunshine Hospital
      • West Perth, Australia, 6005
        • Recruiting
        • The Perth Blood Institute
        • Principal Investigator:
          • Ross Baker
  • Austria
      • Vienna, Austria, 1140
        • Active, not recruiting
        • Hanusch Krankenhaus
  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
        • Contact:
          • Phone Number: +3216346880
        • Principal Investigator:
          • Ann Janssens
      • Sint-Niklaas, Belgium, B-9100
        • Recruiting
        • Vitaz
        • Principal Investigator:
          • Vanessa Van Hende
        • Contact:
          • Phone Number: +32 3 760 2985
  • Brazil
      • Barretos, Brazil, 14784400
        • Recruiting
        • Fundação Pio XII - Hospital de Câncer de Barretos
        • Principal Investigator:
          • Nelson Siqueira de Castro
      • Botucatu, Brazil, 18618-687
        • Recruiting
        • Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP
        • Contact:
          • Phone Number: +55 14 3880-1663
        • Principal Investigator:
          • Rafael Dezen Gaiolla
      • Campinas, Brazil, 13083-878
        • Recruiting
        • Hemocentro Unicamp
        • Principal Investigator:
          • Fernando Vieira Pericole de Souza
        • Contact:
          • Phone Number: 55 19 3521-8630
      • Cascavel, Brazil, 85806-300
        • Recruiting
        • Hospital Uopeccan - Centro de Pesquisa Clinica
        • Contact:
          • Phone Number: +55 (45) 9 9135 1056
        • Principal Investigator:
          • Gabriela Almeida Garcia
      • Curitiba, Brazil, 80810050
        • Active, not recruiting
        • Centro Integrado de Oncologia de Curitiba
      • Curitiba, Brazil, 81520060
        • Recruiting
        • Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
        • Contact:
          • Phone Number: (41) 9998-46033
        • Principal Investigator:
          • João Samuel de Holanda Farias
      • Passo Fundo, Brazil, 99010090
        • Recruiting
        • Instituto do Câncer - Hospital São Vicente de Paulo
        • Contact:
          • Phone Number: 555421034130
        • Principal Investigator:
          • Moema Nene Santos
      • Porto Alegre, Brazil, 90110270
        • Recruiting
        • Centro Gaucho Integrado - Mae de Deus Center
        • Contact:
          • Phone Number: +55 51 33072943
        • Principal Investigator:
          • Marcelo Capra
      • Ribeirão Preto, Brazil, 14051-140
        • Recruiting
        • Hospital de Clínicas de Ribeirão Preto
        • Contact:
          • Phone Number: 16 98112-6986
        • Principal Investigator:
          • Diego Villa Clé
      • Santo André, Brazil, 09060-650
        • Recruiting
        • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
        • Contact:
          • Phone Number: +55.11.4993-5491
        • Principal Investigator:
          • Debora Rodrigues Bonito
      • São José do Rio Preto, Brazil, 15090-000
        • Recruiting
        • Centro Integrado de Pesquisa Clinica
        • Contact:
          • Phone Number: +55 (17)3201-5000
        • Principal Investigator:
          • Carlos Eduardo Miguel
      • São Paulo, Brazil, 08270-120
        • Recruiting
        • Hospital Santa Marcelina
        • Contact:
          • Phone Number: 55 11 22173766
        • Principal Investigator:
          • Patricia de Paulo Giacon
      • São Paulo, Brazil, 01321-001
        • Recruiting
        • Hospital BP
        • Contact:
          • Phone Number: 551135056675
        • Principal Investigator:
          • Danielle Leão Cordeiro de Farias
      • São Paulo, Brazil, 05403-000
        • Recruiting
        • Hospital da Clinicas da Faculdade de Medicina da USP
        • Contact:
          • Phone Number: +55 11 4573-7631
        • Principal Investigator:
          • Raphael Costa Bandeira de Melo
  • Canada
      • Montreal, Canada, H3A 1A1
        • Terminated
        • Royal Victoria Hospital-Montreal
      • Québec, Canada, G1J 1Z4
        • Recruiting
        • Hopital de L'Enfant Jesus
        • Contact:
          • Phone Number: 418-525-4444 ext. 0
        • Principal Investigator:
          • Robert Delage
      • Winnipeg, Canada, R3E 0V9
        • Active, not recruiting
        • Cancer Care Manitoba
  • Chile
      • Santiago, Chile, 7580206
        • Active, not recruiting
        • Inmunocel
      • Santiago, Chile, 8320000
        • Active, not recruiting
        • CeCim Biocinetic
      • Temuco, Chile, 4780000
        • Recruiting
        • Sociedad de Investigaciones Médicas Limitada
        • Contact:
          • Phone Number: +56974316500
        • Principal Investigator:
          • Eduardo Yañez
      • Viña del Mar, Chile, 2520000
        • Active, not recruiting
        • Centro de Investigaciones Clínicas Viña del Mar (CIC)
  • China
      • Changsha, China, 410011
        • Active, not recruiting
        • The Second Xiangya Hospital of Central South University
      • Changsha, China, 410013
        • Active, not recruiting
        • Hunan Cancer Hospital
      • Guangzhou, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Principal Investigator:
          • He Huang
        • Contact:
          • Phone Number: +86 13798032244
      • Guangzhou, China, 510515
        • Active, not recruiting
        • Southern Medical University Nanfang Hospital
      • Haikou, China, 570311
        • Active, not recruiting
        • Hainan General Hospital
      • Hangzhou, China, 310003
        • Recruiting
        • First Affiliated Hosp of College of Med, Zhejiang University
        • Contact:
          • Phone Number: 86 13505716779
        • Principal Investigator:
          • Jie Jin
      • Hangzhou, China, 310009
        • Active, not recruiting
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Hefei, China, 230001
        • Recruiting
        • Anhui Provincial Hospital
        • Contact:
          • Phone Number: 8613856007984
        • Principal Investigator:
          • Xingbing Wang
      • Hefei, China, 231200
        • Recruiting
        • The Second Hospital of Anhui Medical University
        • Contact:
          • Phone Number: +86 13855147434
        • Principal Investigator:
          • Zhai Zhimin
      • Nanchang, China, 330029
        • Active, not recruiting
        • Jiangxi Provincial Cancer Hospital
      • Nanning, China, 530021
        • Active, not recruiting
        • Guangxi Medical University Affiliated Tumor Hospital
      • Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Phone Number: 13651680209
        • Principal Investigator:
          • Junning Cao
      • Tianjin, China, 300052
        • Active, not recruiting
        • Tianjin Medical University General Hospital
      • Tianjin, China, 300020
        • Active, not recruiting
        • Blood Institute of the Chinese Academy of Medical science
      • Wuhan, China, 430022
        • Active, not recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Wuhan, China, 430030
        • Active, not recruiting
        • Wu Han Tongji Hospital
      • Yiwu, China, 322000
        • Active, not recruiting
        • The Fourth Affiliated Hospital Zhejiang University School of Medicine
      • Ürümqi, China, 830000
        • Active, not recruiting
        • Affiliated Cancer Hospital of Xinjiang Medical University
  • Czechia
      • Brno, Czechia, 62500
        • Recruiting
        • Fakultni Nemocnice Brno
        • Principal Investigator:
          • Jiri Mayer
        • Contact:
          • Phone Number: (+420) 532 233 642
      • Hradec Králové, Czechia, 500 05
        • Recruiting
        • Fakultni nemocnice Hradec Kralove
        • Principal Investigator:
          • Martin Simkovic
        • Contact:
          • Phone Number: +420 777 846 836
      • Ostrava, Czechia, 708 52
        • Recruiting
        • Fakultni nemocnice Ostrava
        • Contact:
          • Phone Number: (+420) 597 372 749
        • Principal Investigator:
          • Jana Mihalyova
      • Pilsen, Czechia, 305 99
        • Recruiting
        • Fakultni Nemocnice Plzen
        • Contact:
          • Phone Number: (+420) 377 103 722
        • Principal Investigator:
          • Daniel Lysak
      • Prague, Czechia, 10034
        • Recruiting
        • Fakultní Nemocnice Královské Vinohrady
        • Principal Investigator:
          • Jan Novak
        • Contact:
          • Phone Number: (+420) 267 163 530
      • Prague, Czechia, 12808
        • Active, not recruiting
        • Vseobecna fakultni nemocnice v Praze
  • France
      • La Roche-sur-Yon, France, 85000
        • Recruiting
        • CHD Vendee
        • Principal Investigator:
          • Bruno Villemagne
        • Contact:
          • Phone Number: +33251446173
      • Le Mans, France, 72000
        • Recruiting
        • Centre Hospitalier du Mans
        • Contact:
          • Phone Number: +33 2.43.43.29.59
        • Principal Investigator:
          • Kamel Laribi
      • Limoges, France, 87042
        • Recruiting
        • Centre Hospitalier Universitaire (Limoges) (CHU DUPUYTREN 1)
        • Contact:
          • Phone Number: +33(0)555 05 88 22
        • Principal Investigator:
          • Nataliya Dmutruk
      • Nantes, France, 44093
        • Recruiting
        • CHU de Nantes - Hotel Dieu
        • Principal Investigator:
          • Anne Lok
      • Nice, France, 06189
        • Recruiting
        • Centre Antoine Lacassagne
        • Contact:
          • Phone Number: 33 (0)4 92 03 10 35
        • Principal Investigator:
          • Luca INCHIAPPA
      • Paris, France, 75651
        • Recruiting
        • Hopital de la Pitie Salpetriere
        • Contact:
          • Phone Number: +33 1 42 16 15 96
        • Principal Investigator:
          • Damien Roos-Weil
      • Pierre-Bénite, France, 69495
        • Recruiting
        • Centre Hospitalier Lyon Sud
        • Contact:
          • Phone Number: +33 4 78 86 43 07
        • Principal Investigator:
          • Emmanuelle Ferrant
      • Rennes, France, 35033
        • Recruiting
        • Hôpital de Pontchaillou
        • Principal Investigator:
          • Sophie De Guibert
        • Contact:
          • Phone Number: +33 299 28 4291
      • Rouen, France, 76038
        • Recruiting
        • Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen
        • Principal Investigator:
          • Stephane Lepretre
        • Contact:
          • Phone Number: + 33 2 32 08 22 23
      • Tours, France, 37044
        • Recruiting
        • CHRU De Tours
        • Principal Investigator:
          • Caroline Dartigeas
        • Contact:
          • Phone Number: +33 2 47 47 37 12
  • Germany
      • Dortmund, Germany, 44309
        • Active, not recruiting
        • Gemeinschaftspraxis für Hämatologie und Onkologie (Gefos)
      • Dresden, Germany, 01307
        • Active, not recruiting
        • Universitaetsklinikum Carl Gustav Carus an der TU Dresden, Medizinische Klinik und Poliklinik 1
      • Dresden, Germany, 01307
        • Recruiting
        • Onkologische Gemeinschaftspraxis / BAG
        • Principal Investigator:
          • Lutz Jacobasch
        • Contact:
          • Phone Number: +4935144950701
      • Ulm, Germany, 89075
        • Active, not recruiting
        • Universitätsklinikum Ulm
  • Hungary
      • Debrecen, Hungary, 4004
        • Recruiting
        • Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
        • Principal Investigator:
          • Arpad Illes
        • Contact:
          • Phone Number: 3652255196
      • Szombathely, Hungary, 9700
        • Active, not recruiting
        • Markusovszky Egyetemi Oktatokorhaz
  • Israel
      • Jerusalem, Israel, 9112001
        • Active, not recruiting
        • Hadassah Medical Center
      • Tel Aviv, Israel, 6423906
        • Active, not recruiting
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Alessandria, Italy, 15100
        • Recruiting
        • Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
        • Contact:
          • Phone Number: 39 0131 206440
        • Principal Investigator:
          • Gioacchino Catania
      • Bologna, Italy, 40138
        • Active, not recruiting
        • Policlinico Sant'Orsola Malpighi
      • Meldola, Italy, 47014
        • Recruiting
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
        • Principal Investigator:
          • Gerardo Musuraca
        • Contact:
          • Phone Number: +390543739100
      • Milan, Italy, 20132
        • Recruiting
        • IRCCS Ospedale San Raffaele
        • Principal Investigator:
          • Paolo Ghia
        • Contact:
          • Phone Number: 39.02.26434797
      • Milan, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia
        • Principal Investigator:
          • Enrico Derenzini
        • Contact:
          • Phone Number: +39 02 57489403
      • Reggio Emilia, Italy, 42122
        • Active, not recruiting
        • Azienda Unita Sanitaria Locale di Reggio Emilia
  • Japan
      • Kumamoto, Japan, 860-8556
        • Active, not recruiting
        • Kumamoto University Hospital
      • Yamagata, Japan, 990-9585
        • Recruiting
        • Yamagata University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hisayuki Yokoyama
  • New Zealand
      • Dunedin, New Zealand, 9016
        • Active, not recruiting
        • Dunedin Hospital
      • Hamilton, New Zealand, 3204
        • Active, not recruiting
        • Waikato Hospital
      • Newtown, New Zealand, 6242
        • Recruiting
        • Momentum Clinical Research
        • Principal Investigator:
          • Robert Weinkove
      • Papatoetoe, New Zealand, 2025
        • Recruiting
        • Middlemore Clinical Trials
        • Contact:
          • Phone Number: + 64 212 618 734
        • Principal Investigator:
          • James Liang
  • Poland
      • Biała Podlaska, Poland, 21500
        • Active, not recruiting
        • KO-MED Centra Kliniczne
      • Bydgoszcz, Poland, 85-168
        • Recruiting
        • Szpital Uniwersytecki nr 1 im. Antoniego Jurasza
        • Contact:
          • Phone Number: +48508508810
        • Principal Investigator:
          • Marta Sobas
      • Gdansk, Poland, 80-952
        • Active, not recruiting
        • Uniwersyteckie Centrum Kliniczne
      • Katowice, Poland, 40519
        • Recruiting
        • Pratia Onkologia Katowice
        • Principal Investigator:
          • Sabastian Grosicki
        • Contact:
          • Phone Number: +48 600 388 282
      • Krakow, Poland, 30-510
        • Recruiting
        • Pratia MCM Krakow
        • Principal Investigator:
          • Wojciech Jurczak
        • Contact:
          • Phone Number: +48451077231
      • Lublin, Poland, 20-081
        • Active, not recruiting
        • Klinika Hematoonkologii i Transplantacji Szpiku,Samodzielny Publiczny Szpital Kliniczny Nr 1
      • Skórzewo, Poland, 60-185
        • Recruiting
        • AIDPORT Sp. z o.o.
        • Principal Investigator:
          • Michal Kwiatek
      • Wroclaw, Poland, 50-367
        • Recruiting
        • Uniwersytecki Szpital Kliniczny Klinika
        • Contact:
          • Phone Number: +48 784 25 76
        • Principal Investigator:
          • Tomasz Wrobel
  • South Korea
      • Busan, South Korea, 47392
        • Recruiting
        • Inje Univ Busan Paik Hospital
        • Contact:
          • Phone Number: +82-51-890-6407
        • Principal Investigator:
          • Won Lee
      • Seocho-Gu, South Korea, 06591
        • Recruiting
        • The Catholic University of Korea-Seoul St. Mary's Hospital
        • Principal Investigator:
          • Ki-Seong Eom
        • Contact:
          • Phone Number: 02-2228-6056
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Phone Number: 82 2 2072 3079
        • Principal Investigator:
          • Ja Min Byun
      • Seoul, South Korea, 06351
        • Active, not recruiting
        • Samsung Medical Center
  • Spain
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Contact:
          • Phone Number: +34 93 556 5647
        • Principal Investigator:
          • Miguel Arguello de Tomas
      • Barcelona, Spain, 08036
        • Active, not recruiting
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 8035
        • Active, not recruiting
        • Hospital Universitari Vall d'Hebron
      • L'Hospitalet de Llobregat, Spain, 08908
        • Active, not recruiting
        • Hospital Duran i Reynals
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal
        • Principal Investigator:
          • Javier Lopez Jimenez
        • Contact:
          • Phone Number: +34 91 3368637
      • Madrid, Spain, 28031
        • Active, not recruiting
        • Hospital Universitario Infanta Leonor-INTERNAL MED
      • Majadahonda, Spain, 28222
        • Active, not recruiting
        • Hospital Universitario Puerta de Hierro Majadahonda
      • Marbella, Spain, 29600
        • Recruiting
        • Hospital Costa Del Sol
        • Principal Investigator:
          • Angeles Medina Perez
        • Contact:
          • Phone Number: +34 (951) 976-957
      • Pamplona, Spain, 31008
        • Recruiting
        • Clinica Universitaria De Navarra
        • Contact:
          • Phone Number: 913531920 ext. 7511
        • Principal Investigator:
          • Rocio Figueroa Mora
      • Pamplona, Spain, 31008
        • Recruiting
        • Hospital De Navarra
        • Principal Investigator:
          • Jose Maria Arguiñano Perez
        • Contact:
          • Phone Number: +34848428428
      • Santander, Spain, 39008
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla
        • Principal Investigator:
          • Lucrecia Yañez San Segundo
        • Contact:
          • Phone Number: 942 31 52 75
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
          • Phone Number: +34619848594
        • Principal Investigator:
          • Alicia Rodriguez Fernandez
      • Seville, Spain, 41013
        • Active, not recruiting
        • Hospital Universitario Virgen del Rocio
  • Taiwan
      • Changhua, Taiwan, 710
        • Recruiting
        • Chang Bing Show Chwan Memorial Hospital
        • Principal Investigator:
          • Cheng-Shyong Chang
        • Contact:
          • Phone Number: +886-4-7813-888#70290
      • Chiayi County, Taiwan, 61363
        • Active, not recruiting
        • Chang Gung Memorial Hospital - Chiayi
      • Tainan, Taiwan, 704
        • Active, not recruiting
        • National Cheng-Kung Uni. Hosp.
      • Taipei, Taiwan, 112
        • Recruiting
        • Koo Foundation Sun Yan-Sen Cancer Center
        • Contact:
          • Phone Number: +886-2-28970011
        • Principal Investigator:
          • Tran-Der Tan
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 6500
        • Active, not recruiting
        • Gazi University Faculty of Medicine
      • Balçova, Turkey (Türkiye), 35100
        • Active, not recruiting
        • 9 Eylul University Hospital
      • Bornova, Turkey (Türkiye), 35040
        • Active, not recruiting
        • Ege Üniversitesi
      • Faith, Turkey (Türkiye), 34732
        • Recruiting
        • Istanbul University Istanbul Medicine Faculty
        • Contact:
          • Phone Number: +90 533 575 90 96
        • Principal Investigator:
          • Mustafa Nuri Yenerel
      • Istanbul, Turkey (Türkiye), 34365
        • Active, not recruiting
        • American Hospital
      • Istanbul, Turkey (Türkiye), 34457
        • Completed
        • Acıbadem Maslak Hastanesi
      • Mamak, Turkey (Türkiye), 06590
        • Recruiting
        • Ankara University Medicine Hospital
        • Principal Investigator:
          • Muhit Özcan
        • Contact:
          • Phone Number: 90 505 502 50 50
  • United Kingdom
      • Bristol, United Kingdom, BS2 8ED
        • Recruiting
        • Bristol Haematology and Oncology Centre
        • Principal Investigator:
          • Sanne Lugthart
        • Contact:
          • Phone Number: 0117 3421121
      • Cottingham, United Kingdom, HU16 5JQ
        • Recruiting
        • Castle Hill Hospital
        • Principal Investigator:
          • David Allsup
        • Contact:
          • Phone Number: 01482 46 12 89
      • Leicester, United Kingdom, LE1 5WW
        • Active, not recruiting
        • HOPE Centre
      • London, United Kingdom, EC1A 7BE
        • Active, not recruiting
        • St Bartholomew's Hospital
      • Swansea, United Kingdom, SA2 8QA
        • Recruiting
        • Singleton Hospital
        • Contact:
          • Phone Number: 01792 285301
        • Principal Investigator:
          • Unmesh Mohite
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Recruiting
        • Pacific Cancer Medical Center, Inc
        • Contact:
          • Phone Number: 714-999-1465
        • Principal Investigator:
          • Veena Charu
      • Cerritos, California, United States, 90703
        • Recruiting
        • TOI Clinical Research
        • Contact:
          • Phone Number: 562-693-4477
        • Principal Investigator:
          • MICHAEL DEL ROSARIO
      • Palo Alto, California, United States, 94305
        • Recruiting
        • Stanford School of Medicine-Cancer Clinical Trials Office
        • Principal Investigator:
          • Bita Fakhri
        • Contact:
          • Phone Number: 650-498-6000
      • San Marcos, California, United States, 92069
        • Active, not recruiting
        • California Cancer Associates for Research and Excellence
    • Florida
      • Fort Myers, Florida, United States, 33916-2233
        • Recruiting
        • Florida Cancer Specialists
        • Contact:
          • Phone Number: 727-216-1143
        • Principal Investigator:
          • Jennifer Cultrera
      • Saint Augustine, Florida, United States, 32086
        • Recruiting
        • Cancer Specialists of North Florida -St Augustine
        • Contact:
          • Phone Number: 904-538-4488
        • Principal Investigator:
          • Ayed Ayed
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Florida Cancer Specialists East
        • Contact:
          • Phone Number: 561-366-4100
        • Principal Investigator:
          • Shachar Peles
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Active, not recruiting
        • Hematology Oncology Clinic
      • New Orleans, Louisiana, United States, 70112
        • Active, not recruiting
        • Tulane Cancer Center Office of Clinical Research
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • American Oncology Partners of Maryland, PA
        • Contact:
          • Phone Number: 301-571-0019
        • Principal Investigator:
          • Victor Priego
    • Montana
      • Billings, Montana, United States, 59102
        • Recruiting
        • St. Vincent Frontier Cancer Center
        • Principal Investigator:
          • Patrick Cobb
        • Contact:
          • Phone Number: 406-238-6685
    • Pennsylvania
      • York, Pennsylvania, United States, 17403
        • Active, not recruiting
        • Cancer Care Associates of York
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Active, not recruiting
        • Prisma Health Cancer Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute SCRI
        • Contact:
          • Phone Number: 423-622-6212
        • Principal Investigator:
          • Bertrand Anz III
    • Texas
      • Houston, Texas, United States, 77025
        • Active, not recruiting
        • Kelsey Research Foundation
      • Kingwood, Texas, United States, 77339
        • Recruiting
        • Lumi Research
        • Principal Investigator:
          • David Nguyen
    • Virginia
      • Richmond, Virginia, United States, 23230
        • Recruiting
        • Virginia Cancer Institute
        • Contact:
          • Phone Number: 804-287-3000
        • Principal Investigator:
          • Yuvraj Choudhary
    • Washington
      • Spokane, Washington, United States, 99208
        • Recruiting
        • Medical Oncology Associates, PS
        • Principal Investigator:
          • Arvind Chaudhry
        • Contact:
          • Phone Number: 509-462-2273
      • Spokane, Washington, United States, 99218
        • Active, not recruiting
        • MultiCare Health System Institute for Research and Innovation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pirtobrutinib Part 1
Participants will receive pirtobrutinib orally.
Drug: Pirtobrutinib
Administered orally.
Other Names:
  • LOXO-305
  • LY3527727
Experimental: Pirtobrutinib Part 2
Participants will receive pirtobrutinib orally.
Drug: Pirtobrutinib
Administered orally.
Other Names:
  • LOXO-305
  • LY3527727
Active Comparator: Ibrutinib Part 1
Participants will receive ibrutinib orally.
Drug: Ibrutinib
Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
ORR as assessed by independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria
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)
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
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 2 years and 3 months)
ORR as assessed by independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-Free Survival (EFS)
Time Frame: 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)
EFS by IRC per iwCLL 2018 criteria
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)
Overall Survival (OS)
Time Frame: Randomization to death from any cause (approximately 6 years)
OS
Randomization to death from any cause (approximately 6 years)
Time to Next Treatment (TTNT)
Time Frame: Randomization to initiation of the next systemic anticancer therapy for CLL/SLL or death from any cause, whichever occurs first (approximately 6 years)
TTNT
Randomization to initiation of the next systemic anticancer therapy for CLL/SLL or death from any cause, whichever occurs first (approximately 6 years)
IRC-assessed Progression-Free Survival (PFS)
Time Frame: Randomization to PD (per iwCLL 2018 criteria) or death from any cause (approximately 5 years 8 months)
PFS by IRC per iwCLL 2018 criteria
Randomization to PD (per iwCLL 2018 criteria) or death from any cause (approximately 5 years 8 months)
Investigator assessed Progression-Free Survival (PFS)
Time Frame: Randomization to PD (per iwCLL 2018 criteria) or death from any cause (approximately 5 years 8 months)
PFS by Investigator per iwCLL 2018 criteria
Randomization to PD (per iwCLL 2018 criteria) or death from any cause (approximately 5 years 8 months)
Duration of Response (DOR)
Time Frame: 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)
DOR by IRC and Investigator by iwCLL 2018 Criteria.
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)
Time to Worsening (TTW) of CLL/SLL Related Symptoms
Time Frame: Randomization to time to worsening symptoms (approximately 4 years)
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.
Randomization to time to worsening symptoms (approximately 4 years)
Comparative Tolerability
Time Frame: From Baseline to Treatment Discontinuation for Any Reason (approximately 4 years)
Comparative Tolerability measured by proportion of time with high side-effect burden
From Baseline to Treatment Discontinuation for Any Reason (approximately 4 years)
Percentage of Participants Achieving DOR Part 2
Time Frame: 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)
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loxo Oncology, Inc.

Collaborators

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2022

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

February 15, 2022

First Submitted That Met QC Criteria

February 15, 2022

First Posted (Actual)

February 24, 2022

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18281
  • J2N-OX-JZNU (Other Identifier: Eli Lilly and Company)
  • LOXO-BTK-20030 (Other Identifier: Eli Lilly and Company)
  • 2023-507699-38-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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