A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) | NCT05254743 | Trialant

A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) | NCT05254743 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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

Pacific Cancer Medical Center, IncRecruiting

Anaheim, California 92801, United States

-Contact

714-999-1465

Veena CharuPrincipal Investigator

TOI Clinical ResearchRecruiting

Cerritos, California 90703, United States

Stanford School of Medicine-Cancer Clinical Trials OfficeRecruiting

Palo Alto, California 94305, United States

California Cancer Associates for Research and ExcellenceActive, not recruiting

San Marcos, California 92069, United States

Florida Cancer SpecialistsRecruiting

Fort Myers, Florida 33916-2233, United States

Cancer Specialists of North Florida -St AugustineRecruiting

Saint Augustine, Florida 32086, United States

Florida Cancer Specialists EastRecruiting

West Palm Beach, Florida 33401, United States

Hematology Oncology ClinicActive, not recruiting

Baton Rouge, Louisiana 70809, United States

Tulane Cancer Center Office of Clinical ResearchActive, not recruiting

New Orleans, Louisiana 70112, United States

American Oncology Partners of Maryland, PARecruiting

Bethesda, Maryland 20817, United States

St. Vincent Frontier Cancer CenterRecruiting

Billings, Montana 59102, United States

Cancer Care Associates Of YorkActive, not recruiting

York, Pennsylvania 17403, United States

Prisma Health Cancer InstituteActive, not recruiting

Greenville, South Carolina 29605, United States

Sarah Cannon Research Institute SCRIRecruiting

Nashville, Tennessee 37203, United States

Kelsey Research FoundationActive, not recruiting

Houston, Texas 77025, United States

Lumi ResearchRecruiting

Kingwood, Texas 77339, United States

Virginia Cancer InstituteRecruiting

Richmond, Virginia 23230, United States

Medical Oncology Associates, PSRecruiting

Spokane, Washington 99208, United States

MultiCare Health System Institute for Research and InnovationActive, not recruiting

Spokane, Washington 99218, United States

Alexander FlemingRecruiting

Ciudad Autónoma de Buenos Aire, C1426ANZ, Argentina

-Contact

+54 9 11 4051-0781

Hospital Privado De ComunidadActive, not recruiting

Mar del Plata, 7600, Argentina

Clínica de Nefrología, Urología y Enfermedades CardiovascularesRecruiting

Santa Fe, 3000, Argentina

One Clinical ResearchActive, not recruiting

Nedlands, 6009, Australia

Western Health, Sunshine HospitalActive, not recruiting

St Albans, 3021, Australia

The Perth Blood InstituteRecruiting

West Perth, 6005, Australia

Hanusch KrankenhausActive, not recruiting

Vienna, 1140, Austria

Universitaire Ziekenhuizen Leuven - Campus GasthuisbergRecruiting

Leuven, 3000, Belgium

VITAZRecruiting

Sint-Niklaas, B-9100, Belgium

Fundação Pio XII - Hospital de Câncer de BarretosRecruiting

Barretos, 14784400, Brazil

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

Botucatu, 18618-687, Brazil

Hemocentro UnicampRecruiting

Campinas, 13083-878, Brazil

Hospital Uopeccan - Centro de Pesquisa ClinicaRecruiting

Cascavel, 85806-300, Brazil

Centro Integrado de Oncologia de CuritibaActive, not recruiting

Curitiba, 80810050, Brazil

Hospital Erasto Gaertner - Liga Paranaense de Combate ao CâncerRecruiting

Curitiba, 81520060, Brazil

Instituto do Câncer - Hospital São Vicente de PauloRecruiting

Passo Fundo, 99010090, Brazil

Centro Gaucho Integrado - Mae de Deus CenterRecruiting

Porto Alegre, 90110270, Brazil

Hospital de Clínicas de Ribeirão PretoRecruiting

Ribeirão Preto, 14051-140, Brazil

CEPHO - Centro de Estudos e Pesquisas de Hematologia e OncologiaRecruiting

Santo André, 09060-650, Brazil

Centro Integrado de Pesquisa ClinicaRecruiting

São José do Rio Preto, 15090-000, Brazil

Hospital BPRecruiting

São Paulo, 01321-001, Brazil

Hospital da Clinicas da Faculdade de Medicina da USPRecruiting

São Paulo, 05403-000, Brazil

Hospital Santa MarcelinaRecruiting

São Paulo, 08270-120, Brazil

Royal Victoria Hospital-MontrealTerminated

Montreal, H3A 1A1, Canada

Hopital de L'Enfant JesusRecruiting

Québec, G1J 1Z4, Canada

Cancer Care ManitobaActive, not recruiting

Winnipeg, R3E 0V9, Canada

InmunocelActive, not recruiting

Santiago, 7580206, Chile

CeCim BiocineticActive, not recruiting

Santiago, 8320000, Chile

Sociedad de Investigaciones Médicas LimitadaRecruiting

Temuco, 4780000, Chile

Centro de Investigaciones Clínicas Viña del Mar (CIC)Active, not recruiting

Viña del Mar, 2520000, Chile

The Second Xiangya Hospital of Central South UniversityActive, not recruiting

Changsha, 410011, China

Hunan Cancer HospitalActive, not recruiting

Changsha, 410013, China

Sun Yat-sen University Cancer CenterRecruiting

Guangzhou, 510060, China

Southern Medical University Nanfang HospitalRecruiting

Guangzhou, 510515, China

Hainan General HospitalActive, not recruiting

Haikou, 570311, China

First Affiliated Hosp of College of Med, Zhejiang UniversityRecruiting

Hangzhou, 310003, China

The Second Affiliated Hospital of Zhejiang University School of MedicineActive, not recruiting

Hangzhou, 310009, China

Anhui Provincial HospitalRecruiting

Hefei, 230001, China

The Second Hospital of Anhui Medical UniversityRecruiting

Hefei, 231200, China

Jiangxi Provincial Cancer HospitalActive, not recruiting

Nanchang, 330029, China

Guangxi Medical University Affiliated Tumor HospitalRecruiting

Nanning, 530021, China

Fudan University Shanghai Cancer CenterRecruiting

Shanghai, 200032, China

Blood Institute of the Chinese Academy of Medical scienceActive, not recruiting

Tianjin, 300020, China

Tianjin Medical University General HospitalActive, not recruiting

Tianjin, 300052, China

Affiliated Cancer Hospital of Xinjiang Medical UniversityActive, not recruiting

Ürümqi, 830000, China

Union Hospital Tongji Medical College Huazhong University of Science and TechnologyActive, not recruiting

Wuhan, 430022, China

Wu Han Tongji HospitalActive, not recruiting

Wuhan, 430030, China

The Fourth Affiliated Hospital Zhejiang University School of MedicineActive, not recruiting

Yiwu, 322000, China

Fakultni nemocnice BrnoRecruiting

Brno, 62500, Czechia

Fakultni nemocnice Hradec KraloveRecruiting

Hradec Králové, 500 05, Czechia

Fakultni Nemocnice OstravaRecruiting

Ostrava, 708 52, Czechia

Fakultni Nemocnice PlzenRecruiting

Pilsen, 305 99, Czechia

Fakultni nemocnice Kralovske VinohradyRecruiting

Prague, 10034, Czechia

Vseobecna fakultni nemocnice v PrazeRecruiting

Prague, 12808, Czechia

CHD VendeeRecruiting

La Roche-sur-Yon, 85000, France

Centre Hospitalier du MansRecruiting

Le Mans, 72000, France

Centre Hospitalier Universitaire (Limoges) (CHU DUPUYTREN 1)Recruiting

Limoges, 87042, France

CHU de Nantes - Hotel DieuRecruiting

Nantes, 44093, France

Centre Antoine LacassagneRecruiting

Nice, 06189, France

Hopital de la Pitie SalpetriereRecruiting

Paris, 75651, France

Centre Hospitalier Lyon SudRecruiting

Pierre-Bénite, 69495, France

Hôpital de PontchaillouRecruiting

Rennes, 35033, France

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

Rouen, 76038, France

CHRU De ToursRecruiting

Tours, 37044, France

Gemeinschaftspraxis für Hämatologie und Onkologie (Gefos)Active, not recruiting

Dortmund, 44309, Germany

Onkologische Gemeinschaftspraxis / BAGRecruiting

Dresden, 01307, Germany

Universitaetsklinikum Carl Gustav Carus an der TU Dresden, Medizinische Klinik und Poliklinik 1Active, not recruiting

Dresden, 01307, Germany

Universitätsklinikum UlmActive, not recruiting

Ulm, 89075, Germany

Debreceni Egyetem Orvos-es Egészsegtudomanyi CentrumRecruiting

Debrecen, 4004, Hungary

Markusovszky Egyetemi OktatokorhazActive, not recruiting

Szombathely, 9700, Hungary

Hadassah Medical CenterRecruiting

Jerusalem, 9112001, Israel

Tel Aviv Sourasky Medical CenterActive, not recruiting

Tel Aviv, 6423906, Israel

Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare ArrigoRecruiting

Alessandria, 15100, Italy

Policlinico Sant'Orsola MalpighiActive, not recruiting

Bologna, 40138, Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei TumoriRecruiting

Meldola, 47014, Italy

IRCCS Ospedale San RaffaeleRecruiting

Milan, 20132, Italy

Istituto Europeo di OncologiaRecruiting

Milan, 20141, Italy

Azienda Unita Sanitaria Locale di Reggio EmiliaActive, not recruiting

Reggio Emilia, 42122, Italy

Kumamoto University HospitalActive, not recruiting

Kumamoto, 860-8556, Japan

Yamagata University HospitalRecruiting

Yamagata, 990-9585, Japan

Dunedin HospitalActive, not recruiting

Dunedin, 9016, New Zealand

Waikato HospitalActive, not recruiting

Hamilton, 3204, New Zealand

Momentum Clinical ResearchRecruiting

Newtown, 6242, New Zealand

Middlemore Clinical TrialsRecruiting

Papatoetoe, 2025, New Zealand

KO-MED Centra KliniczneActive, not recruiting

Biała Podlaska, 21500, Poland

Szpital Uniwersytecki nr 1 im. Antoniego JuraszaRecruiting

Bydgoszcz, 85-168, Poland

Uniwersyteckie Centrum KliniczneRecruiting

Gdansk, 80-952, Poland

Pratia Onkologia KatowiceRecruiting

Katowice, 40519, Poland

Pratia MCM KrakowRecruiting

Krakow, 30-510, Poland

Klinika Hematoonkologii i Transplantacji Szpiku,Samodzielny Publiczny Szpital Kliniczny Nr 1Active, not recruiting

Lublin, 20-081, Poland

AIDPORT Sp. z o.o.Recruiting

Skórzewo, 60-185, Poland

Uniwersytecki Szpital Kliniczny KlinikaRecruiting

Wroclaw, 50-367, Poland

Inje Univ Busan Paik HospitalRecruiting

Busan, 47392, South Korea

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

Seocho-Gu, 06591, South Korea

-Contact

02-2228-6056

Seoul National University HospitalRecruiting

Seoul, 03080, South Korea

Samsung Medical CenterActive, not recruiting

Seoul, 06351, South Korea

Hospital de la Santa Creu i Sant PauRecruiting

Barcelona, 08025, Spain

Hospital Clinic de BarcelonaActive, not recruiting

Barcelona, 08036, Spain

Hospital Universitari Vall d'HebronRecruiting

Barcelona, 8035, Spain

Hospital Duran i ReynalsActive, not recruiting

L'Hospitalet de Llobregat, 08908, Spain

Hospital Universitario Infanta Leonor-INTERNAL MEDRecruiting

Madrid, 28031, Spain

Hospital Universitario Ramón y CajalRecruiting

Madrid, 28034, Spain

Hospital Universitario Puerta de Hierro MajadahondaRecruiting

Majadahonda, 28222, Spain

Hospital Costa Del SolRecruiting

Marbella, 29600, Spain

Clinica Universitaria De NavarraRecruiting

Pamplona, 31008, Spain

Hospital De NavarraRecruiting

Pamplona, 31008, Spain

Hospital Universitario Marqués de ValdecillaRecruiting

Santander, 39008, Spain

Hospital Universitario Virgen MacarenaRecruiting

Seville, 41009, Spain

Hospital Universitario Virgen Del RocioRecruiting

Seville, 41013, Spain

Chang Bing Show Chwan Memorial HospitalRecruiting

Changhua, 710, Taiwan

Chang Gung Memorial Hospital - ChiayiRecruiting

Chiayi County, 61363, Taiwan

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+886-5-3621000 ext:2106

National Cheng-Kung Uni. Hosp.Active, not recruiting

Tainan, 704, Taiwan

Koo Foundation Sun Yan-Sen Cancer CenterRecruiting

Taipei, 112, Taiwan

Gazi University Faculty of MedicineActive, not recruiting

Ankara, 6500, Turkey (Türkiye)

9 Eylul University HospitalActive, not recruiting

Balçova, 35100, Turkey (Türkiye)

Ege ÜniversitesiActive, not recruiting

Bornova, 35040, Turkey (Türkiye)

Istanbul University Istanbul Medicine FacultyRecruiting

Faith, 34732, Turkey (Türkiye)

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+90 533 575 90 96

American HospitalRecruiting

Istanbul, 34365, Turkey (Türkiye)

Acıbadem Maslak HastanesiCompleted

Istanbul, 34457, Turkey (Türkiye)

Ankara University Medicine HospitalRecruiting

Mamak, 06590, Turkey (Türkiye)

Bristol Haematology and Oncology CentreRecruiting

Bristol, BS2 8ED, United Kingdom

HOPE CentreActive, not recruiting

Leicester, LE1 5WW, United Kingdom

St Bartholomew's HospitalActive, not recruiting

London, EC1A 7BE, United Kingdom

Singleton HospitalRecruiting

Swansea, SA2 8QA, United Kingdom