A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

May 18, 2026 updated by: Loxo Oncology, Inc.

A Phase 2, Open-Label, Randomized Study Evaluating the Efficacy and Safety of 3 Doses of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Who Previously Received Treatment With a Covalent Bruton Tyrosine Kinase Inhibitor

The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. The purpose of Part 2 of this study is to evaluate pirtobrutinib monotherapy in participants with treatment-naïve CLL/SLL with 17p deletions. Participation in Part 1 is expected to last approximately 3 years. Participation in Part 2 is expected to last up to 2 years.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Drug: Pirtobrutinib

Study Type

Interventional

Enrollment (Estimated)

249

Phase

Phase 2

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

Name: Physicians interested in becoming principal investigators please contact
Email: clinical_inquiry_hub@lilly.com

Study Locations

Australia
- - Adelaide, Australia, 5042
    - Recruiting
    - Flinders Medical Centre
    - Principal Investigator:
      
      Kate Manos
  - Bankstown, Australia, 2200
    - Recruiting
    - Bankstown-Lidcombe Hospital
    - Principal Investigator:
      
      Adrian Yeung
  - Box Hill, Australia, 3128
    - Recruiting
    - Box Hill Hospital
    - Principal Investigator:
      
      Ahmad Zargari
  - Coffs Harbour, Australia, 2450
    - Recruiting
    - Coffs Harbour Health Campus
    - Principal Investigator:
      
      Kyle Crassini
  - Hobart, Australia, 7000
    - Recruiting
    - Royal Hobart Hospital
    - Principal Investigator:
      
      Rosemary Harrup
    - Contact:
      
      Phone Number: 61 3 6166 6655
  - Kurralta Park, Australia, 5037
    - Recruiting
    - ICON Cancer Centre - Kurralta Park
    - Principal Investigator:
      
      Ka Chun Cheung
  - Traralgon, Australia, 3844
    - Recruiting
    - Latrobe Regional Health
    - Principal Investigator:
      
      Michael Ashby
  - Waratah, Australia, 2298
    - Recruiting
    - Calvary Mater Newcastle
    - Contact:
      
      Phone Number: 0240143021
    - Principal Investigator:
      
      Alex Holmes
  - West Perth, Australia, 6005
    - Recruiting
    - The Perth Blood Institute - West Perth
    - Principal Investigator:
      
      Ross Baker
  - Woolloongabba, Australia, 4102
    - Recruiting
    - Princess Alexandra Hospital
    - Principal Investigator:
      
      Sasanka Handunnetti
Belgium
- - Anderlecht, Belgium, 1070
    - Recruiting
    - Institut Jules Bordet
    - Principal Investigator:
      
      Virginie De Wilde
  - Bruges, Belgium, 8000
    - Recruiting
    - AZ Sint-Jan Brugge-Oostende AV
    - Contact:
      
      Phone Number: 3250452320
    - Principal Investigator:
      
      Sylvia Snauwaert
  - Ghent, Belgium, 9000
    - Recruiting
    - UZ Gent
    - Principal Investigator:
      
      Fritz Offner
    - Contact:
      
      Phone Number: +32 9 332 21 25
  - La Louvière, Belgium, 7100
    - Recruiting
    - Groupe Jolimont
    - Principal Investigator:
      
      VANESSA DELRIEU
  - Leuven, Belgium, 3000
    - Recruiting
    - UZ Leuven
    - Principal Investigator:
      
      Ann Janssens
  - Ottignies, Belgium, 1340
    - Recruiting
    - Clinique Saint Pierre
    - Principal Investigator:
      
      Thierry Connerotte
  - Roeselare, Belgium, 8800
    - Recruiting
    - AZ Delta VZW
    - Principal Investigator:
      
      Lien Deleu
    - Contact:
      
      Phone Number: 003251237322
  - Sint-Niklaas, Belgium, B-9100
    - Recruiting
    - AZ Nikolaas
    - Principal Investigator:
      
      Vanessa Van Hende
  - Verviers, Belgium, 4800
    - Recruiting
    - CHR Verviers - La Tourelle
    - Principal Investigator:
      
      Gaetan Vanstraelen
    - Contact:
      
      Phone Number: 087219418
Canada
- - Barrie, Canada, L4M 6M2
    - Recruiting
    - Royal Victoria Regional Health Centre
    - Principal Investigator:
      
      Derek Nay
  - Saskatoon, Canada, S7N4H4
    - Recruiting
    - Saskatoon Cancer Centre
    - Principal Investigator:
      
      Julie Stakiw
Czechia
- - Brno, Czechia, 625 00
    - Recruiting
    - Fakultní nemocnice Brno Bohunice
    - Principal Investigator:
      
      Michael Doubek
    - Contact:
      
      Phone Number: 0042053233562
  - Hradec Králové, Czechia, 500 05
    - Recruiting
    - Fakultni nemocnice Hradec Kralove
    - Principal Investigator:
      
      Martin Simkovic
    - Contact:
      
      Phone Number: +420495832886
  - Prague, Czechia, 100 34
    - Recruiting
    - Fakultni nemocnice Kralovske Vinohrady
    - Principal Investigator:
      
      Jan Novak
    - Contact:
      
      Phone Number: +420606901110
  - Prague, Czechia, 12808
    - Recruiting
    - Vseobecna fakultni nemocnice v Praze
    - Contact:
      
      Phone Number: +420224966845
    - Principal Investigator:
      
      Martin Spacek
Denmark
- - Aarhus, Denmark, 8200
    - Recruiting
    - Aarhus Universitetshospital, Skejby
    - Principal Investigator:
      
      Hans Bentzen
  - Odense, Denmark, 5000
    - Recruiting
    - Odense Universitetshospital
    - Principal Investigator:
      
      Annika Rewes
France
- - Argenteuil, France, 95107
    - Recruiting
    - Centre Hospitalier d'Argenteuil Victor Dupouy
    - Principal Investigator:
      
      driss chaoui
  - Caen, France, 14033
    - Recruiting
    - Centre Hospitalier Universitaire de Caen - Hopital Cote de Nacre
    - Principal Investigator:
      
      Baptiste DELAPIERRE
  - Le Mans, France, 72000
    - Recruiting
    - Centre Hospitalier du Mans
    - Principal Investigator:
      
      Kamel Laribi
    - Contact:
      
      Phone Number: +33255463467
  - Mulhouse, France, 68100
    - Recruiting
    - Groupe Hospitalier de la Région de Mulhouse et Sud Alsace - Hôpital Emile Muller
    - Principal Investigator:
      
      Bernard Drenou
  - Nice, France, 06189
    - Recruiting
    - Centre Antoine-Lacassagne
    - Principal Investigator:
      
      Luca INCHIAPPA
  - Tours, France, 37044 Cedex 9
    - Recruiting
    - Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
    - Principal Investigator:
      
      Caroline Dartigeas
Germany
- - Cologne, Germany, 50677
    - Recruiting
    - MV-Zentrum für Onkologie und Hämatologie
    - Principal Investigator:
      
      Jan-Phillip Weber
  - Frankfurt, Germany, 60389
    - Recruiting
    - Centrum fur Hamatologie und Onkologie Bethanien
    - Contact:
      
      Phone Number: 00496956005621
    - Principal Investigator:
      
      Christian Schmitt
  - Göttingen, Germany, 37073
    - Recruiting
    - OSP Göttingen
    - Principal Investigator:
      
      Michael Metz
    - Contact:
      
      Phone Number: 0049551488795915
  - Hanover, Germany, 30171
    - Recruiting
    - Onkologisches Ambulanzzentrum Hannover
    - Contact:
      
      Phone Number: 004989979680
    - Principal Investigator:
      
      Michael Gärtner
  - Hösbach, Germany, 63768
    - Recruiting
    - Klinikum Aschaffenburg-Alzenau
    - Principal Investigator:
      
      Manfred Welslau
    - Contact:
      
      Phone Number: 0049 60214527391
  - Koblenz, Germany, 56068
    - Recruiting
    - Invo Institut Fur Versorgungsforschung in Der Onkologie
    - Principal Investigator:
      
      Rudolf Weide
    - Contact:
      
      Phone Number: 49 261 921 5693-0
Greece
- - Athens, Greece, 106 76
    - Recruiting
    - Evangelismos General Hospital of Athens
    - Principal Investigator:
      
      Maria Bouzani
    - Contact:
      
      Phone Number: +302107201721
  - Chaïdári, Greece, 12462
    - Recruiting
    - Attikon General University Hospital
    - Contact:
      
      Phone Number: 0030 2105832307
    - Principal Investigator:
      
      Vasiliki Pappa
  - Thessaloniki, Greece, 570 10
    - Recruiting
    - G. Papanikolaou General Hospital
    - Principal Investigator:
      
      Niki Stavroyianni
    - Contact:
      
      Phone Number: +302313307533
  - Αthens, Greece, 11526
    - Recruiting
    - General Hospital of Athens "Laiko"
    - Principal Investigator:
      
      Theodoros Vassilakopoulos
Hungary
- - Budapest, Hungary, 1088
    - Recruiting
    - Semmelweis Egyetem
    - Contact:
      
      Phone Number: 36208258660
    - Principal Investigator:
      
      ZSOLT GYORGY Nagy
  - Budapest, Hungary, 1097
    - Recruiting
    - Dél-Pesti Centrumkórház
    - Principal Investigator:
      
      Zoltan Matrai
    - Contact:
      
      Phone Number: +3630 455 8218
  - Pécs, Hungary, 7624
    - Recruiting
    - Pécsi Tudományegyetem Klinikai Központ
    - Principal Investigator:
      
      Hussain Alizadeh
    - Contact:
      
      Phone Number: +36 72 536 000
  - Szeged, Hungary, 6725
    - Recruiting
    - Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
    - Contact:
      
      Phone Number: +36704391136
    - Principal Investigator:
      
      Szabolcs Modok
Italy
- - Bari, Italy, 70124
    - Recruiting
    - A.O.U.C. Policlinico di Bari
    - Contact:
      
      Phone Number: 0805593471
    - Principal Investigator:
      
      Pellegrino Musto
  - Cona, Italy, 44124
    - Recruiting
    - Azienda Ospedaliero Universitaria S.Anna
    - Principal Investigator:
      
      Antonio Cuneo
    - Contact:
      
      Phone Number: +390532236977
  - Florence, Italy, 50134
    - Recruiting
    - Azienda Ospedaliera Universitaria Careggi
    - Principal Investigator:
      
      alessandro sanna
    - Contact:
      
      Phone Number: 00390557947958
  - Milan, Italy, 20162
    - Recruiting
    - ASST Grande Ospedale Metropolitano Niguarda
    - Principal Investigator:
      
      Anna Maria Frustaci
  - Novara, Italy, 28100
    - Recruiting
    - Azienda Ospedaliero Universitaria Maggiore della Carità
    - Contact:
      
      Phone Number: +39 03213733880
    - Principal Investigator:
      
      Riccardo Moia
  - Padova, Italy, 35128
    - Recruiting
    - Azienda Ospedale - Università Padova
    - Contact:
      
      Phone Number: 0498217809
    - Principal Investigator:
      
      Andrea Visentin
  - Palermo, Italy, 90146
    - Recruiting
    - Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO
    - Principal Investigator:
      
      Caterina Patti
    - Contact:
      
      Phone Number: +390916802773
  - Perugia, Italy, 06132
    - Recruiting
    - AO Santa Maria della Misericordia
    - Principal Investigator:
      
      PAOLO SPORTOLETTI
    - Contact:
      
      Phone Number: +390755783990
  - Roma, Italy, 00161
    - Recruiting
    - AOU Policlinico Umberto I
    - Principal Investigator:
      
      Maurizio Martelli
    - Contact:
      
      Phone Number: 0649974773
  - Roma, Italy, 00168
    - Recruiting
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore
    - Principal Investigator:
      
      LUCA LAURENTI
    - Contact:
      
      Phone Number: +39 0630157833
Poland
- - Bydgoszcz, Poland, 85-048
    - Recruiting
    - IN VIVO
    - Principal Investigator:
      
      Jaroslaw Czyz
  - Katowice, Poland, 40-519
    - Recruiting
    - Pratia Onkologia Katowice
    - Principal Investigator:
      
      Sebastian Grosicki
    - Contact:
      
      Phone Number: +4832 3499751
  - Krakow, Poland, 30-727
    - Recruiting
    - Pratia MCM Krakow
    - Principal Investigator:
      
      Wojciech Jurczak
    - Contact:
      
      Phone Number: +48 602338290
  - Skórzewo, Poland, 60-185
    - Recruiting
    - Aidport Sp. z o.o.
    - Principal Investigator:
      
      Michal Kwiatek
  - Wroclaw, Poland, 50-367
    - Recruiting
    - Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
    - Principal Investigator:
      
      Tomasz Wrobel
    - Contact:
      
      Phone Number: 501419272
Romania
- - Bucharest, Romania, 022328
    - Recruiting
    - Fundeni Clinical Institute
    - Contact:
      
      Phone Number: 40212750500
    - Principal Investigator:
      
      Ana Maria Moldovianu
  - Bucharest, Romania, 030171
    - Recruiting
    - Spitalul Clinic Coltea
    - Principal Investigator:
      
      Gabriela Borsaru
    - Contact:
      
      Phone Number: 0744150652
  - Cluj-Napoca, Romania, 400015
    - Recruiting
    - Institutul Oncologic Cluj
    - Principal Investigator:
      
      Ciprian Tomuleasa
    - Contact:
      
      Phone Number: 400741337480
  - Craiova, Romania, 200143
    - Recruiting
    - Spitalul Clinic Municipal Filantropia Craiova
    - Contact:
      
      Phone Number: 0735439439
    - Principal Investigator:
      
      Ocroteala Luminita
  - Iași, Romania, 700483
    - Recruiting
    - Institutul Regional de Oncologie
    - Principal Investigator:
      
      Catalin Danaila
    - Contact:
      
      Phone Number: 40722565781
  - Ovidiu, Romania, 905900
    - Recruiting
    - Ovidius Clinical Hospital OCH
    - Contact:
      
      Phone Number: 0724877013
    - Principal Investigator:
      
      Andreea Caloian
Slovakia
- - Banská Bystrica, Slovakia, 975 17
    - Recruiting
    - Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
    - Contact:
      
      Phone Number: +421915803313
    - Principal Investigator:
      
      Anna Vallova
  - Bratislava, Slovakia, 833 10
    - Recruiting
    - Narodny onkologicky ustav
    - Principal Investigator:
      
      Eva Mikuskova
  - Košice, Slovakia, 040 11
    - Recruiting
    - Univerzitna nemocnica L. Pasteura Kosice
    - Contact:
      
      Phone Number: +421556404410
    - Principal Investigator:
      
      Tomas Guman
  - Martin, Slovakia, 036 59
    - Recruiting
    - Univerzitna Nemocnica Martin
    - Contact:
      
      Phone Number: 421902101385
    - Principal Investigator:
      
      Juraj Sokol
South Korea
- - Busan, South Korea, 49241
    - Recruiting
    - Pusan National University Hospital
    - Principal Investigator:
      
      Ho-Jin Shin
    - Contact:
      
      Phone Number: +821089371258
  - Hwasun-gun, South Korea, 58128
    - Recruiting
    - Chonnam National University Hwasun Hospital
    - Principal Investigator:
      
      DEOK HWAN YANG
  - Seoul, South Korea, 03080
    - Recruiting
    - Seoul National University Hospital
    - Principal Investigator:
      
      Ja Min Byun
  - Seoul, South Korea, 06351
    - Recruiting
    - Samsung Medical Center
    - Principal Investigator:
      
      Seok Jin Kim
  - Seoul, South Korea, 06591
    - Recruiting
    - The Catholic Univ. of Korea Seoul St. Mary's Hospital
    - Principal Investigator:
      
      Ki-Seong Eom
    - Contact:
      
      Phone Number: 82222586056
  - Seoul, South Korea, 07345
    - Recruiting
    - The Catholic University of Korea, Yeouido St. Mary's Hospital
    - Contact:
      
      Phone Number: +821042324067
    - Principal Investigator:
      
      Youngwoo Jeon
Spain
- - Barcelona, Spain, 08035
    - Recruiting
    - Hospital Universitari Vall d'Hebron
    - Contact:
      
      Phone Number: +34 93 274 61 00 EXT 3806
    - Principal Investigator:
      
      Francisco Bosch Albareda
  - Barcelona, Spain, 08036
    - Recruiting
    - Hospital Clinic de Barcelona
    - Contact:
      
      Phone Number: 932275400
    - Principal Investigator:
      
      Pablo Mozas
  - L'Hospitalet Del Llobregat, Spain, 08908
    - Recruiting
    - Institut Català d'Oncologia - L'Hospitalet
    - Principal Investigator:
      
      Ana Oliveira Ramos
  - Madrid, Spain, 28031
    - Recruiting
    - Hospital Universitario Infanta Leonor
    - Principal Investigator:
      
      José Ángel Hernández Rivas
    - Contact:
      
      Phone Number: 911918932
  - Madrid, Spain, 28034
    - Recruiting
    - Hospital Universitario Ramon y Cajal
    - Principal Investigator:
      
      Javier Lopez Jimenez
    - Contact:
      
      Phone Number: 34913368637
  - Madrid, Spain, 28027
    - Recruiting
    - Clinica Universidad de Navarra
    - Principal Investigator:
      
      Carlos Grande Garcia
  - Madrid, Spain, 28033
    - Recruiting
    - MD Anderson Cancer Center
    - Principal Investigator:
      
      Adolfo de la Fuente Burguera
  - Majadahonda, Spain, 28222
    - Recruiting
    - Hospital Universitario Puerta de Hierro Majadahonda
    - Contact:
      
      Phone Number: 91 191 69 71
    - Principal Investigator:
      
      JOSE GARCIA VELA
  - Marbella, Spain, 29603
    - Recruiting
    - Hospital Costa del Sol
    - Principal Investigator:
      
      Angeles Medina Perez
    - Contact:
      
      Phone Number: +34951976957
  - Oviedo, Spain, 33011
    - Recruiting
    - Hospital Universitario Central de Asturias
    - Principal Investigator:
      
      Ángel Ramírez Payer
    - Contact:
      
      Phone Number: 985108000
  - Salamanca, Spain, 37007
    - Recruiting
    - Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
    - Contact:
      
      Phone Number: 34923291100
    - Principal Investigator:
      
      Almudena Navarro Bailon
  - Santander, Spain, 39008
    - Recruiting
    - Hospital Universitario Marqués de Valdecilla
    - Principal Investigator:
      
      LUCRECIA YANEZ SAN SEGUNDO
    - Contact:
      
      Phone Number: 34942315321
  - Seville, Spain, 41013
    - Recruiting
    - Hospital Universitario Virgen del Rocío
    - Principal Investigator:
      
      Fatima de la Cruz Vicente
    - Contact:
      
      Phone Number: 34 955013277
  - Seville, Spain, 41009
    - Recruiting
    - Hospital Universitario Virgen Macarena
    - Principal Investigator:
      
      Alicia Rodriguez Fernandez
    - Contact:
      
      Phone Number: 3495049697
Turkey (Türkiye)
- - Adapazarı, Turkey (Türkiye), 54100
    - Recruiting
    - Sakarya University School of Medicine
    - Principal Investigator:
      
      Tuba Hacibekiroglu
  - Ankara, Turkey (Türkiye), 06200
    - Recruiting
    - Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi
    - Principal Investigator:
      
      Mehmet Dal
  - Ankara, Turkey (Türkiye), 06620
    - Recruiting
    - Ankara University Health Practice and Research Hospitals
    - Principal Investigator:
      
      Selami Toprak
    - Contact:
      
      Phone Number: 00905326560206
  - Antalya, Turkey (Türkiye), 07090
    - Recruiting
    - Memorial Antalya Hospital
    - Principal Investigator:
      
      Fatih Demirkan
  - Istanbul, Turkey (Türkiye), 34718
    - Recruiting
    - Yeditepe Universitesi Kosuyolu Hastanesi
    - Principal Investigator:
      
      Elif Birtas Atesoglu
  - Izmir, Turkey (Türkiye), 35100
    - Recruiting
    - Ege Universitesi Hastanesi
    - Principal Investigator:
      
      Guray Saydam
    - Contact:
      
      Phone Number: 905325566128
  - Mersin, Turkey (Türkiye), 33200
    - Recruiting
    - VM Medical Park Mersin Hastanesi
    - Principal Investigator:
      
      Anil Tombak
    - Contact:
      
      Phone Number: 111111111
  - Samsun, Turkey (Türkiye), 55139
    - Recruiting
    - Ondokuz Mayıs Üniversitesi
    - Principal Investigator:
      
      Mehmet Turgut
  - İzmit, Turkey (Türkiye), 41380
    - Recruiting
    - Kocaeli Üniversitesi
    - Contact:
      
      Phone Number: 05076771924
    - Principal Investigator:
      
      Ozgur Mehtap
United Kingdom
- - Birmingham, United Kingdom, B9 5SS
    - Recruiting
    - Heartlands Hospital
    - Principal Investigator:
      
      Shankara Paneesha
  - Glasgow, United Kingdom, G12 0YN
    - Recruiting
    - The Beatson West of Scotland Cancer Centre
    - Contact:
      
      Phone Number: 0141 301 7711
    - Principal Investigator:
      
      Mark Rafferty
  - Harrow, United Kingdom, HA1 3UJ
    - Recruiting
    - Northwick Park Hospital
    - Contact:
      
      Phone Number: 02088692742
    - Principal Investigator:
      
      Thomas Lofaro
  - Leeds, United Kingdom, LS9 7TF
    - Recruiting
    - St James's University Hospital
    - Principal Investigator:
      
      Talha Munir
    - Contact:
      
      Phone Number: 01132433144
  - Lincoln, United Kingdom, LN2 5QY
    - Recruiting
    - Lincoln County Hospital
    - Contact:
      
      Phone Number: 07833432491
    - Principal Investigator:
      
      Marios Tsoutsoukis
  - Liverpool, United Kingdom, L7 8YA
    - Recruiting
    - Clatterbridge Cancer Centre - Liverpool
    - Principal Investigator:
      
      Stella Williams
  - London, United Kingdom, W12 0HS
    - Recruiting
    - Hammersmith Hospital
    - Principal Investigator:
      
      Sasha Marks
  - Maidstone, United Kingdom, ME16 9QQ
    - Recruiting
    - Maidstone Hospital
    - Principal Investigator:
      
      Lalita Banerjee
  - Swansea, United Kingdom, SA2 8QA
    - Recruiting
    - Singleton Hospital
    - Principal Investigator:
      
      Unmesh Mohite
    - Contact:
      
      Phone Number: 017920285547
United States
- Arizona
  - Chandler, Arizona, United States, 85224
    - Recruiting
    - Ironwood Cancer & Research Centers
    - Principal Investigator:
      
      Michael Musci
- California
  - Duarte, California, United States, 91010
    - Recruiting
    - City of Hope National Medical Center
    - Contact:
      
      Phone Number: 800-826-4673
    - Principal Investigator:
      
      Alexey Danilov
  - Irvine, California, United States, 92618
    - Recruiting
    - City of Hope National Medical Center
    - Principal Investigator:
      
      Alexey Danilov
    - Contact:
      
      Phone Number: 626-218-2405
  - Palo Alto, California, United States, 94304
    - Recruiting
    - Stanford Cancer Center
    - Principal Investigator:
      
      Bita Fakhri
  - Palo Alto, California, United States, 94304
    - Recruiting
    - Palo Alto Medical Foundation Research Institute (PAMFRI)
    - Principal Investigator:
      
      Roozbeh Mohajer
- Colorado
  - Aurora, Colorado, United States, 80012
    - Recruiting
    - Rocky Mountain Cancer Center
    - Principal Investigator:
      
      John Burke
    - Contact:
      
      Phone Number: 303-418-7639
- Florida
  - Miami, Florida, United States, 33136
    - Recruiting
    - University of Miami Hospital and Clinics, Sylvester Cancer Center
    - Principal Investigator:
      
      Alvaro Alencar
- Georgia
  - Newnan, Georgia, United States, 30265
    - Recruiting
    - City of Hope National Medical Center, Atlanta Cancer Center
    - Principal Investigator:
      
      Sabarish Ayyappan
- Iowa
  - Waukee, Iowa, United States, 50263
    - Recruiting
    - Mission Cancer + Blood
    - Contact:
      
      Phone Number: 515-282-2921
    - Principal Investigator:
      
      Tara Graff
- Kentucky
  - Edgewood, Kentucky, United States, 41017
    - Recruiting
    - Saint Elizabeth Medical Center Edgewood
    - Principal Investigator:
      
      Miguel Islas-Ohlmayer
- Maryland
  - Bethesda, Maryland, United States, 20817
    - Recruiting
    - American Oncology Partners, PA
    - Contact:
      
      Phone Number: 301-571-2016
    - Principal Investigator:
      
      Victor Priego
- Massachusetts
  - Boston, Massachusetts, United States, 02118
    - Recruiting
    - Boston Medical Center
    - Principal Investigator:
      
      Andrew Wilks
- Mississippi
  - Gulfport, Mississippi, United States, 39501
    - Recruiting
    - Gulfport Memorial Hospital
    - Contact:
      
      Phone Number: 228-575-1234
    - Principal Investigator:
      
      Pamela Tuli
- Nevada
  - Henderson, Nevada, United States, 89074
    - Recruiting
    - Comprehensive Cancer Centers of Nevada
    - Principal Investigator:
      
      Anthony Nguyen
- North Carolina
  - Greenville, North Carolina, United States, 27834
    - Recruiting
    - East Carolina University
    - Principal Investigator:
      
      Darla Liles
    - Contact:
      
      Phone Number: 252-744-1015
- Oregon
  - Eugene, Oregon, United States, 97401
    - Recruiting
    - Williamette Valley Cancer Institute & Research Center
    - Principal Investigator:
      
      Jeff Sharman
    - Contact:
      
      Phone Number: 541-683-5001
- Pennsylvania
  - York, Pennsylvania, United States, 17403
    - Recruiting
    - Cancer Care Associates of York
    - Contact:
      
      Phone Number: 717-741-9229
    - Principal Investigator:
      
      Jackson Gao
- Tennessee
  - Germantown, Tennessee, United States, 38138
    - Recruiting
    - The West Clinic, PLLC dba West Cancer Center
    - Contact:
      
      Phone Number: 901-683-0055
    - Principal Investigator:
      
      Jason Chandler
- Texas
  - Austin, Texas, United States, 78705
    - Recruiting
    - USO-Texas Oncology-Central/South Texas
    - Contact:
      
      Phone Number: 512-421-4100
    - Principal Investigator:
      
      Jason Melear
  - The Woodlands, Texas, United States, 77380
    - Recruiting
    - Sarah Cannon Research Institute/SCRI
    - Principal Investigator:
      
      SMO Sarah Cannon Research Inst.
    - Contact:
      
      Phone Number: 999-999-9999
- Virginia
  - Hampton, Virginia, United States, 23666
    - Recruiting
    - USO-Virginia Oncology Associates
    - Principal Investigator:
      
      Celesteann Bremer
    - Contact:
      
      Phone Number: 757-368-0437

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

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Have confirmed diagnosis of CLL/SLL as defined by iwCLL 2018 criteria.
Part 1: Have received prior CLL/SLL treatment
Have received at least 1, but not more than 3 lines of prior treatment for CLL/SLL
Have received a covalent BTK inhibitor
Part 2: Have received no prior treatment for CLL/SLL
- Part 1 - Known 17p deletion status (positive or negative)
- Part 2 - Must have 17p deletion (positive)
Have a requirement for therapy consistent with iwCLL 2018 criteria for initiation of therapy
Capable of swallowing oral study medication.
Have an Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 2.

Exclusion Criteria:

Have received prior treatment with a BTK degrader or a noncovalent BTK inhibitor
Have a history of greater than or equal to (>=) Grade 3 bleeding due to treatment with a BTK inhibitor
Have known or suspected Richter's transformation
Have known or suspected history of central nervous system involvement by CLL/SLL
Previous or concurrent cancer distinct from CLL/SLL within 3 years before randomization. Exceptions may occur with documented sponsor approval. Examples include:
- nonmelanoma skin cancer or lentigo malignant melanoma
- cervical carcinoma in situ
- localized prostate cancer undergoing active surveillance, and
- localized (for example, lymph node negative) breast cancer with no evidence of active disease present for more than 3 years. Individual may be receiving adjuvant hormonal therapy

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)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pirtobrutinib Standard Dose (Dose 1)-Part 1 Pirtobrutinib administered orally.	Drug: Pirtobrutinib Administered Orally.
Experimental: Pirtobrutinib Dose 2-Part 1 Pirtobrutinib administered orally.	Drug: Pirtobrutinib Administered Orally.
Experimental: Pirtobrutinib Dose 3-Part 1 Pirtobrutinib administered orally.	Drug: Pirtobrutinib Administered Orally.
Experimental: Pirtobrutinib Standard Dose-Part 2 Pirtobrutinib administered orally.	Drug: Pirtobrutinib Administered Orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate Time Frame: Baseline up to 3 years	Overall response rate is defined as the proportion of participants who achieve the best overall response at or before the initiation of subsequent anticancer therapy of CR, CRi, nPR, or PR. ORR will be assessed using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 response criteria.	Baseline up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response Time Frame: Baseline up to 3 years	Duration of response is defined as the time from the date of the first documented CR, CRi, nPR, or PR to disease progression (per iwCLL 2018) or death from any cause.	Baseline up to 3 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

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)

January 3, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

September 6, 2024

First Submitted That Met QC Criteria

September 6, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

18877
J2N-MC-JZNX (Other Identifier: Eli Lilly and Company)
2024-515689-15-01 (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 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
ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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.

A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

A Phase 2, Open-Label, Randomized Study Evaluating the Efficacy and Safety of 3 Doses of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Who Previously Received Treatment With a Covalent Bruton Tyrosine Kinase Inhibitor

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.