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NCT05254743PHASE3Recruiting

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

Loxo Oncology, Inc.

Start Date

7/22/2022

Completion Date

1/1/2028

Summary

The purpose of Part 1 of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL; participants may or may not have already had treatment for their cancer. 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Pirtobrutinib

DRUG

Ibrutinib

Interested in This Trial?

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Conditions

Chronic Lymphocytic LeukemiaLeukemia, LymphocyticLeukemia, B-cellSmall Lymphocytic Lymphoma

Locations

Pacific Cancer Medical Center, Inc

Anaheim, California 92801

United States

TOI Clinical Research

Cerritos, California 90703

United States

Stanford School of Medicine-Cancer Clinical Trials Office

Palo Alto, California 94305

United States

California Cancer Associates for Research and Excellence

San Marcos, California 92069

United States

Florida Cancer Specialists

Fort Myers, Florida 33916-2233

United States

Cancer Specialists of North Florida -St Augustine

Saint Augustine, Florida 32086

United States

Florida Cancer Specialists East

West Palm Beach, Florida 33401

United States

Hematology Oncology Clinic

Baton Rouge, Louisiana 70809

United States

Tulane Cancer Center Office of Clinical Research

New Orleans, Louisiana 70112

United States

American Oncology Partners of Maryland, PA

Bethesda, Maryland 20817

United States

St. Vincent Frontier Cancer Center

Billings, Montana 59102

United States

Cancer Care Associates of York

York, Pennsylvania 17403

United States

Prisma Health Cancer Institute

Greenville, South Carolina 29605

United States

Sarah Cannon Research Institute SCRI

Nashville, Tennessee 37203

United States

Kelsey Research Foundation

Houston, Texas 77025

United States

Lumi Research

Kingwood, Texas 77339

United States

Virginia Cancer Institute

Richmond, Virginia 23230

United States

Medical Oncology Associates, PS

Spokane, Washington 99208

United States

MultiCare Health System Institute for Research and Innovation

Spokane, Washington 99218

United States

Alexander Fleming

Ciudad Autónoma de Buenos Aire, C1426ANZ

Argentina

Hospital Privado De Comunidad

Mar del Plata, 7600

Argentina

Clínica de Nefrología, Urología y Enfermedades Cardiovasculares

Santa Fe, 3000

Argentina

One Clinical Research

Nedlands, 6009

Australia

Western Health, Sunshine Hospital

St Albans, 3021

Australia

The Perth Blood Institute

West Perth, 6005

Australia

Hanusch Krankenhaus

Vienna, 1140

Austria

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, 3000

Belgium

VITAZ

Sint-Niklaas, B-9100

Belgium

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, 14784400

Brazil

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

Botucatu, 18618-687

Brazil

Hemocentro Unicamp

Campinas, 13083-878

Brazil

Hospital Uopeccan - Centro de Pesquisa Clinica

Cascavel, 85806-300

Brazil

Centro Integrado de Oncologia de Curitiba

Curitiba, 80810050

Brazil

Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

Curitiba, 81520060

Brazil

Instituto do Câncer - Hospital São Vicente de Paulo

Passo Fundo, 99010090

Brazil

Centro Gaucho Integrado - Mae de Deus Center

Porto Alegre, 90110270

Brazil

Hospital de Clínicas de Ribeirão Preto

Ribeirão Preto, 14051-140

Brazil

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

Santo André, 09060-650

Brazil

Centro Integrado de Pesquisa Clinica

São José do Rio Preto, 15090-000

Brazil

Hospital BP

São Paulo, 01321-001

Brazil

Hospital da Clinicas da Faculdade de Medicina da USP

São Paulo, 05403-000

Brazil

Hospital Santa Marcelina

São Paulo, 08270-120

Brazil

Royal Victoria Hospital-Montreal

Montreal, H3A 1A1

Canada

Hopital de L'Enfant Jesus

Québec, G1J 1Z4

Canada

Cancer Care Manitoba

Winnipeg, R3E 0V9

Canada

Inmunocel

Santiago, 7580206

Chile

CeCim Biocinetic

Santiago, 8320000

Chile

Sociedad de Investigaciones Médicas Limitada

Temuco, 4780000

Chile

Centro de Investigaciones Clínicas Viña del Mar (CIC)

Viña del Mar, 2520000

Chile

The Second Xiangya Hospital of Central South University

Changsha, 410011

China

Hunan Cancer Hospital

Changsha, 410013

China

Sun Yat-sen University Cancer Center

Guangzhou, 510060

China

Southern Medical University Nanfang Hospital

Guangzhou, 510515

China

Hainan General Hospital

Haikou, 570311

China

First Affiliated Hosp of College of Med, Zhejiang University

Hangzhou, 310003

China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, 310009

China

Anhui Provincial Hospital

Hefei, 230001

China

The Second Hospital of Anhui Medical University

Hefei, 231200

China

Jiangxi Provincial Cancer Hospital

Nanchang, 330029

China

Guangxi Medical University Affiliated Tumor Hospital

Nanning, 530021

China

Fudan University Shanghai Cancer Center

Shanghai, 200032

China

Blood Institute of the Chinese Academy of Medical science

Tianjin, 300020

China

Tianjin Medical University General Hospital

Tianjin, 300052

China

Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, 830000

China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430022

China

Wu Han Tongji Hospital

Wuhan, 430030

China

The Fourth Affiliated Hospital Zhejiang University School of Medicine

Yiwu, 322000

China

Fakultni nemocnice Brno

Brno, 62500

Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05

Czechia

Fakultni Nemocnice Ostrava

Ostrava, 708 52

Czechia

Fakultni Nemocnice Plzen

Pilsen, 305 99

Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, 10034

Czechia

Vseobecna fakultni nemocnice v Praze

Prague, 12808

Czechia

CHD Vendee

La Roche-sur-Yon, 85000

France

Centre Hospitalier du Mans

Le Mans, 72000

France

Centre Hospitalier Universitaire (Limoges) (CHU DUPUYTREN 1)

Limoges, 87042

France

CHU de Nantes - Hotel Dieu

Nantes, 44093

France

Centre Antoine Lacassagne

Nice, 06189

France

Hopital de la Pitie Salpetriere

Paris, 75651

France

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495

France

Hôpital de Pontchaillou

Rennes, 35033

France

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

Rouen, 76038

France

CHRU De Tours

Tours, 37044

France

Gemeinschaftspraxis für Hämatologie und Onkologie (Gefos)

Dortmund, 44309

Germany

Onkologische Gemeinschaftspraxis / BAG

Dresden, 01307

Germany

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

Dresden, 01307

Germany

Universitätsklinikum Ulm

Ulm, 89075

Germany

Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum

Debrecen, 4004

Hungary

Markusovszky Egyetemi Oktatokorhaz

Szombathely, 9700

Hungary

Hadassah Medical Center

Jerusalem, 9112001

Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906

Israel

Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo

Alessandria, 15100

Italy

Policlinico Sant'Orsola Malpighi

Bologna, 40138

Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, 47014

Italy

IRCCS Ospedale San Raffaele

Milan, 20132

Italy

Istituto Europeo di Oncologia

Milan, 20141

Italy

Azienda Unita Sanitaria Locale di Reggio Emilia

Reggio Emilia, 42122

Italy

Kumamoto University Hospital

Kumamoto, 860-8556

Japan

Yamagata University Hospital

Yamagata, 990-9585

Japan

Dunedin Hospital

Dunedin, 9016

New Zealand

Waikato Hospital

Hamilton, 3204

New Zealand

Momentum Clinical Research

Newtown, 6242

New Zealand

Middlemore Clinical Trials

Papatoetoe, 2025

New Zealand

KO-MED Centra Kliniczne

Biała Podlaska, 21500

Poland

Szpital Uniwersytecki nr 1 im. Antoniego Jurasza

Bydgoszcz, 85-168

Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-952

Poland

Pratia Onkologia Katowice

Katowice, 40519

Poland

Pratia MCM Krakow

Krakow, 30-510

Poland

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

Lublin, 20-081

Poland

AIDPORT Sp. z o.o.

Skórzewo, 60-185

Poland

Uniwersytecki Szpital Kliniczny Klinika

Wroclaw, 50-367

Poland

Inje Univ Busan Paik Hospital

Busan, 47392

South Korea

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

Seocho-Gu, 06591

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025

Spain

Hospital Clinic de Barcelona

Barcelona, 08036

Spain

Hospital Universitari Vall d'Hebron

Barcelona, 8035

Spain

Hospital Duran i Reynals

L'Hospitalet de Llobregat, 08908

Spain

Hospital Universitario Infanta Leonor-INTERNAL MED

Madrid, 28031

Spain

Hospital Universitario Ramón y Cajal

Madrid, 28034

Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, 28222

Spain

Hospital Costa Del Sol

Marbella, 29600

Spain

Clinica Universitaria De Navarra

Pamplona, 31008

Spain

Hospital De Navarra

Pamplona, 31008

Spain

Hospital Universitario Marqués de Valdecilla

Santander, 39008

Spain

Hospital Universitario Virgen Macarena

Seville, 41009

Spain

Hospital Universitario Virgen Del Rocio

Seville, 41013

Spain

Chang Bing Show Chwan Memorial Hospital

Changhua, 710

Taiwan

Chang Gung Memorial Hospital - Chiayi

Chiayi County, 61363

Taiwan

National Cheng-Kung Uni. Hosp.

Tainan, 704

Taiwan

Koo Foundation Sun Yan-Sen Cancer Center

Taipei, 112

Taiwan

Gazi University Faculty of Medicine

Ankara, 6500

Turkey (Türkiye)

9 Eylul University Hospital

Balçova, 35100

Turkey (Türkiye)

Ege Üniversitesi

Bornova, 35040

Turkey (Türkiye)

Istanbul University Istanbul Medicine Faculty

Faith, 34732

Turkey (Türkiye)

American Hospital

Istanbul, 34365

Turkey (Türkiye)

Acıbadem Maslak Hastanesi

Istanbul, 34457

Turkey (Türkiye)

Ankara University Medicine Hospital

Mamak, 06590

Turkey (Türkiye)

Bristol Haematology and Oncology Centre

Bristol, BS2 8ED

United Kingdom

HOPE Centre

Leicester, LE1 5WW

United Kingdom

St Bartholomew's Hospital

London, EC1A 7BE

United Kingdom

Singleton Hospital

Swansea, SA2 8QA

United Kingdom