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

Last updated: January 9, 2025
Sponsor: Loxo Oncology, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Lymphocytic Leukemia, Chronic

Lymphoproliferative Disorders

Treatment

Pirtobrutinib

Clinical Study ID

NCT06588478
18877
J2N-MC-JZNX
2024-515689-15-00
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with relapsed or refractory 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 study is expected to last approximately 3 years.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have confirmed diagnosis of CLL/SLL as defined by these iwCLL 2018 criteria.

  • 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

  • Have a requirement for therapy consistent with iwCLL 2018 criteria for initiation oftherapy

  • Capable of swallowing oral study medication.

  • Have an Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to

Exclusion

Exclusion Criteria:

  • Have received prior treatment with a BTK degrader and a noncovalent BTK inhibitor

  • Have a history of greater than or equal to (>=) Grade 3 bleeding due to treatmentwith 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 beforerandomization. Exceptions may occur with documented sponsor approval. Examplesinclude:

  • nonmelanoma skin cancer or lentigo maligna melanoma

  • cervical carcinoma in situ

  • localized prostate cancer undergoing active surveillance, and

  • localized (for example, lymph node negative) breast cancer with no evidence ofactive disease present for more than 3 years. Individual may be receivingadjuvant hormonal therapy

Study Design

Total Participants: 249
Treatment Group(s): 1
Primary Treatment: Pirtobrutinib
Phase: 2
Study Start date:
January 03, 2025
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Bankstown-Lidcombe Hospital

    Bankstown, New South Wales 2200
    Australia

    Site Not Available

  • Coffs Harbour Health Campus

    Coffs Harbour, New South Wales 2450
    Australia

    Site Not Available

  • Calvary Mater Newcastle

    Waratah, New South Wales 2298
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • ICON Cancer Centre - Kurralta Park

    Kurralta Park, South Australia 5037
    Australia

    Site Not Available

  • Royal Hobart Hospital

    Hobart, Tasmania 7000
    Australia

    Site Not Available

  • Box Hill Hospital

    Box Hill, Victoria 3128
    Australia

    Site Not Available

  • Latrobe Regional Health

    Traralgon, Victoria 3844
    Australia

    Site Not Available

  • The Perth Blood Institute - West Perth

    West Perth, Western Australia 6005
    Australia

    Site Not Available

  • Clinique Saint Pierre

    Ottignies, Brabant Wallon 1340
    Belgium

    Site Not Available

  • Institut Jules Bordet

    Anderlecht, Bruxelles-Capitale, Région De 1070
    Belgium

    Site Not Available

  • Groupe Jolimont

    La Louvière, Hainaut 7100
    Belgium

    Site Not Available

  • CHR Verviers - La Tourelle

    Verviers, Liège 4800
    Belgium

    Site Not Available

  • UZ Gent

    Gent, Oost-Vlaanderen 9000
    Belgium

    Site Not Available

  • AZ Nikolaas

    Sint-Niklaas, Oost-Vlaanderen B-9100
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, Vlaams-Brabant 3000
    Belgium

    Site Not Available

  • AZ Sint-Jan Brugge-Oostende AV

    Brugge, West-Vlaanderen 8000
    Belgium

    Site Not Available

  • AZ Delta vzw

    Roeselare, West-Vlaanderen 8800
    Belgium

    Site Not Available

  • Royal Victoria Regional Health Centre

    Barrie, Ontario L4M 6M2
    Canada

    Site Not Available

  • CIUSSS- saguenay-Lac-Saint-Jean

    Chicoutimi, Quebec G7H 5H6
    Canada

    Site Not Available

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan S7N4H4
    Canada

    Site Not Available

  • Fakultní nemocnice Brno Bohunice

    Brno, Brno-město 625 00
    Czechia

    Site Not Available

  • Fakultni nemocnice Hradec Kralove

    Hradec Kralove, Hradec Králové 500 05
    Czechia

    Site Not Available

  • Fakultni nemocnice Kralovske Vinohrady

    PRague, Praha 10 100 34
    Czechia

    Site Not Available

  • Vseobecna fakultni nemocnice v Praze

    Praha 2, 12808
    Czechia

    Site Not Available

  • Aarhus Universitetshospital, Skejby

    Aarhus, Midtjylland 8200
    Denmark

    Site Not Available

  • Roskilde Sygehus

    Roskilde, Sjælland 4000
    Denmark

    Site Not Available

  • Odense Universitetshospital

    Odense, Syddanmark 5000
    Denmark

    Site Not Available

  • Centre Antoine-Lacassagne

    Nice, Alpes-Maritimes 06189
    France

    Site Not Available

  • Groupe Hospitalier de la Région de Mulhouse et Sud Alsace - Hôpital Emile Muller

    Mulhouse, Alsace 68100
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre

    Caen, Calvados 14033
    France

    Site Not Available

  • Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE

    Toulouse, Haute-Garonne 31059
    France

    Site Not Available

  • Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau

    Tours, Indre-et-Loire 37044 Cedex 9
    France

    Site Not Available

  • Centre Hospitalier du Mans

    Le Mans, Sarthe 72000
    France

    Site Not Available

  • Centre Hospitalier d'Argenteuil Victor Dupouy

    Argenteuil, Val-d'Oise 95107
    France

    Site Not Available

  • Klinikum Aschaffenburg-Alzenau

    Aschaffenburg, Bayern 63739
    Germany

    Site Not Available

  • Centrum für Hämatologie und Onkologie Bethanien

    Frankfurt, Hessen 60389
    Germany

    Site Not Available

  • OSP Göttingen

    Goettingen, Niedersachsen 37073
    Germany

    Site Not Available

  • Onkologisches Ambulanzzentrum Hannover

    Hannover, Niedersachsen 30171
    Germany

    Site Not Available

  • Gemeinschaftspraxis für Hämatologie und Onkologie Münster

    Münster, Nordrhein-Westfalen 48153
    Germany

    Site Not Available

  • InVO Institut für Versorgungsforschung in der Onkologie

    Koblenz, Rheinland-Pfalz 56068
    Germany

    Site Not Available

  • Evangelismos General Hospital of Athens

    Athens, Attikí 106 76
    Greece

    Site Not Available

  • Attikon General University Hospital

    Chaidari, Attikí 12462
    Greece

    Site Not Available

  • General Hospital of Athens "Laiko"

    Αthens, Attikí 11527
    Greece

    Site Not Available

  • G. Papanikolaou General Hospital

    Thessaloniki, Thessaloníki 570 10
    Greece

    Site Not Available

  • Pécsi Tudományegyetem Klinikai Központ

    Pécs, Baranya 7624
    Hungary

    Site Not Available

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

    Szeged, Csongrád 6725
    Hungary

    Site Not Available

  • Dél-Pesti Centrumkórház

    Budapest, 1097
    Hungary

    Site Not Available

  • Semmelweis University

    Budapest, 1088
    Hungary

    Site Not Available

  • Azienda Ospedaliero Universitaria S.Anna

    Cona, Emilia-Romagna 44124
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

    Roma, Lazio 00168
    Italy

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Lombardia 20162
    Italy

    Site Not Available

  • A.O.U.C. Policlinico di Bari

    Bari, Puglia 70124
    Italy

    Site Not Available

  • Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO

    Palermo, Sicilia 90146
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi

    Firenze, Toscana 50134
    Italy

    Site Not Available

  • AO Santa Maria della Misericordia

    Perugia, Umbria 06132
    Italy

    Site Not Available

  • Azienda Ospedale - Università Padova

    Padova, Veneto 35128
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Maggiore della Carità

    Novara, 28100
    Italy

    Site Not Available

  • AOU Policlinico Umberto I

    Roma, 00161
    Italy

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, Jeonranamdo 58128
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul] 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [Seoul] 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [Seoul] 03722
    Korea, Republic of

    Site Not Available

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

    Seoul, Seoul-teukbyeolsi [Seoul] 06591
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Yeouido St. Mary's Hospital

    Seoul, Seoul-teukbyeolsi [Seoul] 07345
    Korea, Republic of

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

    Wrocław, Dolnośląskie 50-367
    Poland

    Site Not Available

  • Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy

    Bydgoszcz, Kujawsko-pomorskie 85-168
    Poland

    Site Not Available

  • Pratia MCM Krakow

    Kraków, Małopolskie 30-727
    Poland

    Site Not Available

  • AIDPORT Sp. z o.o.

    Skórzewo, Wielkopolskie 60-185
    Poland

    Site Not Available

  • Pratia Onkologia Katowice

    Katowice, Śląskie 40-519
    Poland

    Site Not Available

  • Fundeni Clinical Institute

    Bucuresti, București 022328
    Romania

    Site Not Available

  • Ovidius Clinical Hospital OCH

    Ovidiu, Constanța 905900
    Romania

    Site Not Available

  • Spitalul Clinic Municipal Filantropia Craiova

    Craiova, Dolj 200143
    Romania

    Site Not Available

  • Spitalul Clinic Colțea

    București, 030171
    Romania

    Site Not Available

  • Institutul Oncologic Cluj

    Cluj, 400015
    Romania

    Site Not Available

  • Institutul Regional de Oncologie

    Iași, 700483
    Romania

    Site Not Available

  • Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica

    Banska Bystrica, Banskobystrický Kraj 975 17
    Slovakia

    Site Not Available

  • Narodny onkologicky ustav

    Bratislava, Bratislavský Kraj 833 10
    Slovakia

    Site Not Available

  • Univerzitna Nemocnica L. Pasteura Kosice

    Kosice, Košický Kraj 040 11
    Slovakia

    Site Not Available

  • Univerzitna nemocnica Martin

    Martin, Žilinský Kraj 036 59
    Slovakia

    Site Not Available

  • Hospital Universitario Virgen Macarena

    Sevilla, Andalucía 41009
    Spain

    Site Not Available

  • Hospital Universitario Central de Asturias

    Oviedo, Asturias 33011
    Spain

    Site Not Available

  • Institut Català d'Oncologia (ICO) - Badalona

    Badalona, Barcelona [Barcelona] 08916
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Site Not Available

  • Institut Català d'Oncologia - L'Hospitalet

    L'Hospitalet Del Llobregat, Barcelona [Barcelona] 08908
    Spain

    Site Not Available

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [Cataluña] 08036
    Spain

    Site Not Available

  • Clinica Universidad de Navarra

    Madrid, Madrid, Comunidad De 28027
    Spain

    Site Not Available

  • Hospital Universitario Infanta Leonor

    Madrid, Madrid, Comunidad De 28031
    Spain

    Site Not Available

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad De 28034
    Spain

    Site Not Available

  • MD Anderson Cancer Center

    Madrid, Madrid, Comunidad De 28033
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, Comunidad De 28222
    Spain

    Site Not Available

  • Hospital Costa del Sol

    Marbella, Málaga 29603
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario Quironsalud Madrid

    Madrid, 28223
    Spain

    Site Not Available

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Kocaeli Üniversitesi

    Izmit, Kocaeli 41380
    Turkey

    Site Not Available

  • Sakarya University School of Medicine

    Adapazarı, Sakarya 54100
    Turkey

    Site Not Available

  • Ankara University Health Practice and Research Hospitals

    Ankara, 06620
    Turkey

    Site Not Available

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi

    Ankara, 06200
    Turkey

    Site Not Available

  • Memorial Antalya Hospital

    Antalya, 07090
    Turkey

    Site Not Available

  • Yeditepe Üniversitesi Koşuyolu Hastanesi

    Istanbul, 34718
    Turkey

    Site Not Available

  • Ege Universitesi Hastanesi

    Izmir, 35100
    Turkey

    Site Not Available

  • VM Medical Park Mersin Hastanesi

    Mersin, 33200
    Turkey

    Site Not Available

  • Ondokuz Mayıs Universitesi

    Samsun, 55139
    Turkey

    Site Not Available

  • Maidstone Hospital

    Maidstone, Kent ME16 9QQ
    United Kingdom

    Site Not Available

  • Lincoln County Hospital

    Lincoln, Lincolnshire LN2 5QY
    United Kingdom

    Site Not Available

  • Northwick Park Hospital

    Harrow, London, City Of HA1 3UJ
    United Kingdom

    Site Not Available

  • Hammersmith Hospital

    London, London, City Of W12 0HS
    United Kingdom

    Site Not Available

  • Heartlands Hospital

    Birmingham, B9 5SS
    United Kingdom

    Site Not Available

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN
    United Kingdom

    Site Not Available

  • St James's University Hospital

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • Clatterbridge Cancer Centre - Liverpool

    Liverpool, L7 8YA
    United Kingdom

    Site Not Available

  • Singleton Hospital

    Swansea, SA2 8QA
    United Kingdom

    Site Not Available

  • Ironwood Cancer & Research Centers

    Chandler, Arizona 85224
    United States

    Active - Recruiting

  • City of Hope National Medical Center

    Duarte, California 91010
    United States

    Site Not Available

  • City of Hope National Medical Center

    Irvine, California 92618
    United States

    Site Not Available

  • Palo Alto Medical Foundation Research Institute (PAMFRI)

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Stanford Cancer Center

    Palo Alto, California 94304
    United States

    Site Not Available

  • Rocky Mountain Cancer Center

    Aurora, Colorado 80012
    United States

    Site Not Available

  • University of Miami Hospital and Clinics, Sylvester Cancer Center

    Miami, Florida 33136
    United States

    Site Not Available

  • Mission Cancer + Blood

    Des Moines, Iowa 50309
    United States

    Active - Recruiting

  • Saint Elizabeth Medical Center Edgewood

    Edgewood, Kentucky 41017
    United States

    Site Not Available

  • American Oncology Partners of Maryland, PA

    Bethesda, Maryland 20817
    United States

    Active - Recruiting

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Gulfport Memorial Hospital

    Gulfport, Mississippi 39501
    United States

    Active - Recruiting

  • Clinical Research Alliance

    Westbury, New York 11590
    United States

    Active - Recruiting

  • East Carolina University

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Williamette Valley Cancer Institute & Research Center

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Cancer Care Associates Of York

    York, Pennsylvania 17403
    United States

    Active - Recruiting

  • The West Clinic, PLLC dba West Cancer Center

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Sarah Cannon Research Institute/SCRI

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • USO-Texas Oncology-Central/South Texas

    Austin, Texas 78705
    United States

    Site Not Available

  • USO-Virginia Oncology Associates

    Hampton, Virginia 23666
    United States

    Site Not Available

  • USO-Northwest Cancer Specialists, PC

    Vancouver, Washington 98683
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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