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NCT06588478PHASE2Recruiting

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

Loxo Oncology, Inc.

Start Date

1/3/2025

Completion Date

12/1/2028

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Pirtobrutinib

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Conditions

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Locations

Ironwood Cancer & Research Centers

Chandler, Arizona 85224

United States

City of Hope National Medical Center

Duarte, California 91010

United States

City of Hope National Medical Center

Irvine, California 92618

United States

Palo Alto Medical Foundation Research Institute (PAMFRI)

Palo Alto, California 94304

United States

Stanford Cancer Center

Palo Alto, California 94304

United States

Rocky Mountain Cancer Center

Aurora, Colorado 80012

United States

University of Miami Hospital and Clinics, Sylvester Cancer Center

Miami, Florida 33136

United States

City of Hope National Medical Center, Atlanta Cancer Center

Newnan, Georgia 30265

United States

Mission Cancer + Blood

Waukee, Iowa 50263

United States

Saint Elizabeth Medical Center Edgewood

Edgewood, Kentucky 41017

United States

American Oncology Partners, PA

Bethesda, Maryland 20817

United States

Boston Medical Center

Boston, Massachusetts 02118

United States

Gulfport Memorial Hospital

Gulfport, Mississippi 39501

United States

Comprehensive Cancer Centers of Nevada

Henderson, Nevada 89074

United States

East Carolina University

Greenville, North Carolina 27834

United States

Williamette Valley Cancer Institute & Research Center

Eugene, Oregon 97401

United States

Cancer Care Associates Of York

York, Pennsylvania 17403

United States

The West Clinic, PLLC dba West Cancer Center

Germantown, Tennessee 38138

United States

USO-Texas Oncology-Central/South Texas

Austin, Texas 78705

United States

Sarah Cannon Research Institute/SCRI

The Woodlands, Texas 77380

United States

USO-Virginia Oncology Associates

Hampton, Virginia 23666

United States

Flinders Medical Centre

Adelaide, 5042

Australia

Bankstown-Lidcombe Hospital

Bankstown, 2200

Australia

Box Hill Hospital

Box Hill, 3128

Australia

Coffs Harbour Health Campus

Coffs Harbour, 2450

Australia

Royal Hobart Hospital

Hobart, 7000

Australia

ICON Cancer Centre - Kurralta Park

Kurralta Park, 5037

Australia

Latrobe Regional Health

Traralgon, 3844

Australia

Calvary Mater Newcastle

Waratah, 2298

Australia

The Perth Blood Institute - West Perth

West Perth, 6005

Australia

Princess Alexandra Hospital

Woolloongabba, 4102

Australia

Institut Jules Bordet

Anderlecht, 1070

Belgium

AZ Sint-Jan Brugge-Oostende AV

Bruges, 8000

Belgium

UZ Gent

Ghent, 9000

Belgium

Groupe Jolimont

La Louvière, 7100

Belgium

UZ Leuven

Leuven, 3000

Belgium

Clinique Saint Pierre

Ottignies, 1340

Belgium

AZ Delta vzw

Roeselare, 8800

Belgium

AZ Nikolaas

Sint-Niklaas, B-9100

Belgium

CHR Verviers - La Tourelle

Verviers, 4800

Belgium

Royal Victoria Regional Health Centre

Barrie, L4M 6M2

Canada

Saskatoon Cancer Centre

Saskatoon, S7N4H4

Canada

Fakultní nemocnice Brno Bohunice

Brno, 625 00

Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05

Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, 100 34

Czechia

Vseobecna fakultni nemocnice v Praze

Prague, 12808

Czechia

Aarhus Universitetshospital, Skejby

Aarhus, 8200

Denmark

Odense Universitetshospital

Odense, 5000

Denmark

Centre Hospitalier d'Argenteuil Victor Dupouy

Argenteuil, 95107

France

Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre

Caen, 14033

France

Centre Hospitalier du Mans

Le Mans, 72000

France

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

Mulhouse, 68100

France

Centre Antoine-Lacassagne

Nice, 06189

France

Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau

Tours, 37044 Cedex 9

France

MV-Zentrum für Onkologie und Hämatologie

Cologne, 50677

Germany

Centrum für Hämatologie und Onkologie Bethanien

Frankfurt, 60389

Germany

OSP Göttingen

Göttingen, 37073

Germany

Onkologisches Ambulanzzentrum Hannover

Hanover, 30171

Germany

Klinikum Aschaffenburg-Alzenau

Hösbach, 63768

Germany

InVO Institut für Versorgungsforschung in der Onkologie

Koblenz, 56068

Germany

Evangelismos General Hospital of Athens

Athens, 106 76

Greece

Attikon General University Hospital

Chaïdári, 12462

Greece

G. Papanikolaou General Hospital

Thessaloniki, 570 10

Greece

General Hospital of Athens "Laiko"

Αthens, 11526

Greece

Semmelweis Egyetem

Budapest, 1088

Hungary

Dél-Pesti Centrumkórház

Budapest, 1097

Hungary

Pécsi Tudományegyetem Klinikai Központ

Pécs, 7624

Hungary

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

Szeged, 6725

Hungary

A.O.U.C. Policlinico di Bari

Bari, 70124

Italy

Azienda Ospedaliero Universitaria S.Anna

Cona, 44124

Italy

Azienda Ospedaliera Universitaria Careggi

Florence, 50134

Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162

Italy

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, 28100

Italy

Azienda Ospedale - Università Padova

Padova, 35128

Italy

Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO

Palermo, 90146

Italy

AO Santa Maria della Misericordia

Perugia, 06132

Italy

AOU Policlinico Umberto I

Roma, 00161

Italy

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

Roma, 00168

Italy

IN VIVO

Bydgoszcz, 85-048

Poland

Pratia Onkologia Katowice

Katowice, 40-519

Poland

Pratia MCM Krakow

Krakow, 30-727

Poland

AIDPORT Sp. z o.o.

Skórzewo, 60-185

Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

Wroclaw, 50-367

Poland

Fundeni Clinical Institute

Bucharest, 022328

Romania

Spitalul Clinic Colțea

Bucharest, 030171

Romania

Institutul Oncologic Cluj

Cluj-Napoca, 400015

Romania

Spitalul Clinic Municipal Filantropia Craiova

Craiova, 200143

Romania

Institutul Regional de Oncologie

Iași, 700483

Romania

Ovidius Clinical Hospital OCH

Ovidiu, 905900

Romania

Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica

Banská Bystrica, 975 17

Slovakia

Narodny onkologicky ustav

Bratislava, 833 10

Slovakia

Univerzitna Nemocnica L. Pasteura Kosice

Košice, 040 11

Slovakia

Univerzitna nemocnica Martin

Martin, 036 59

Slovakia

Pusan National University Hospital

Busan, 49241

South Korea

Chonnam National University Hwasun Hospital

Hwasun-gun, 58128

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

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

Seoul, 06591

South Korea

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

Seoul, 07345

South Korea

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital Clínic de Barcelona

Barcelona, 08036

Spain

Institut Català d'Oncologia - L'Hospitalet

L'Hospitalet Del Llobregat, 08908

Spain

Clinica Universidad de Navarra

Madrid, 28027

Spain

Hospital Universitario Infanta Leonor

Madrid, 28031

Spain

MD Anderson Cancer Center

Madrid, 28033

Spain

Hospital Universitario Ramón y Cajal

Madrid, 28034

Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, 28222

Spain

Hospital Costa del Sol

Marbella, 29603

Spain

Hospital Universitario Central de Asturias

Oviedo, 33011

Spain

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

Salamanca, 37007

Spain

Hospital Universitario Marqués de Valdecilla

Santander, 39008

Spain

Hospital Universitario Virgen Macarena

Seville, 41009

Spain

Hospital Universitario Virgen Del Rocio

Seville, 41013

Spain

Sakarya University School of Medicine

Adapazarı, 54100

Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi

Ankara, 06200

Turkey (Türkiye)

Ankara University Health Practice and Research Hospitals

Ankara, 06620

Turkey (Türkiye)

Memorial Antalya Hospital

Antalya, 07090

Turkey (Türkiye)

Yeditepe Üniversitesi Koşuyolu Hastanesi

Istanbul, 34718

Turkey (Türkiye)

Ege Universitesi Hastanesi

Izmir, 35100

Turkey (Türkiye)

Kocaeli Üniversitesi

İzmit, 41380

Turkey (Türkiye)

VM Medical Park Mersin Hastanesi

Mersin, 33200

Turkey (Türkiye)

Ondokuz Mayıs Universitesi

Samsun, 55139

Turkey (Türkiye)

Heartlands Hospital

Birmingham, B9 5SS

United Kingdom

The Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN

United Kingdom

Northwick Park Hospital

Harrow, HA1 3UJ

United Kingdom

St James's University Hospital

Leeds, LS9 7TF

United Kingdom

Lincoln County Hospital

Lincoln, LN2 5QY

United Kingdom

Clatterbridge Cancer Centre - Liverpool

Liverpool, L7 8YA

United Kingdom

Hammersmith Hospital

London, W12 0HS

United Kingdom

Maidstone Hospital

Maidstone, ME16 9QQ

United Kingdom

Singleton Hospital

Swansea, SA2 8QA

United Kingdom