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New hope in blood cancer battle: Next-Gen drug tested against standard therapy

NCT ID NCT05254743

Disease control Sponsor: Loxo Oncology, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 3 times

Summary

This study tests whether a newer drug called pirtobrutinib works better than the current standard drug ibrutinib for people with chronic lymphocytic leukemia or small lymphocytic lymphoma. About 737 adults who need treatment for their cancer will be randomly assigned to receive one of the two drugs. The goal is to see which drug shrinks tumors more effectively and keeps the cancer from growing longer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 737 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia B-cell neoplasm chronic lymphocytic leukemia/small lymphocytic lymphoma hematologic disorder Leukemia, B-Cell lymphoid leukemia non-Hodgkin lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic lymphocytic leukemia Leukemia, B-cell Leukemia, lymphocytic Small lymphocytic lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    93 sites in 22 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 9 Eylul University Hospital

    ACTIVE_NOT_RECRUITING

    Balçova, 35100, Turkey (Türkiye)

  • AIDPORT Sp. z o.o.

    RECRUITING

    Skórzewo, 60-185, Poland

  • Acıbadem Maslak Hastanesi

    COMPLETED

    Istanbul, 34457, Turkey (Türkiye)

  • Affiliated Cancer Hospital of Xinjiang Medical University

    ACTIVE_NOT_RECRUITING

    Ürümqi, 830000, China

  • Alexander Fleming

    RECRUITING

    Ciudad Autónoma de Buenos Aire, C1426ANZ, Argentina

  • American Hospital

    RECRUITING

    Istanbul, 34365, Turkey (Türkiye)

  • American Oncology Partners of Maryland, PA

    RECRUITING

    Bethesda, Maryland, 20817, United States

  • Anhui Provincial Hospital

    RECRUITING

    Hefei, 230001, China

  • Ankara University Medicine Hospital

    RECRUITING

    Mamak, 06590, Turkey (Türkiye)

  • Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo

    RECRUITING

    Alessandria, 15100, Italy

  • Azienda Unita Sanitaria Locale di Reggio Emilia

    ACTIVE_NOT_RECRUITING

    Reggio Emilia, 42122, Italy

  • Blood Institute of the Chinese Academy of Medical science

    ACTIVE_NOT_RECRUITING

    Tianjin, 300020, China

  • Bristol Haematology and Oncology Centre

    RECRUITING

    Bristol, BS2 8ED, United Kingdom

  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

    RECRUITING

    Santo André, 09060-650, Brazil

  • CHD Vendee

    RECRUITING

    La Roche-sur-Yon, 85000, France

  • CHRU De Tours

    RECRUITING

    Tours, 37044, France

  • CHU de Nantes - Hotel Dieu

    RECRUITING

    Nantes, 44093, France

  • California Cancer Associates for Research and Excellence

    ACTIVE_NOT_RECRUITING

    San Marcos, California, 92069, United States

  • Cancer Care Associates Of York

    ACTIVE_NOT_RECRUITING

    York, Pennsylvania, 17403, United States

  • Cancer Care Manitoba

    ACTIVE_NOT_RECRUITING

    Winnipeg, R3E 0V9, Canada

  • Cancer Specialists of North Florida -St Augustine

    RECRUITING

    Saint Augustine, Florida, 32086, United States

  • CeCim Biocinetic

    ACTIVE_NOT_RECRUITING

    Santiago, 8320000, Chile

  • Centre Antoine Lacassagne

    RECRUITING

    Nice, 06189, France

  • Centre Hospitalier Lyon Sud

    RECRUITING

    Pierre-Bénite, 69495, France

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

    RECRUITING

    Limoges, 87042, France

  • Centre Hospitalier du Mans

    RECRUITING

    Le Mans, 72000, France

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

    RECRUITING

    Rouen, 76038, France

  • Centro Gaucho Integrado - Mae de Deus Center

    RECRUITING

    Porto Alegre, 90110270, Brazil

  • Centro Integrado de Oncologia de Curitiba

    ACTIVE_NOT_RECRUITING

    Curitiba, 80810050, Brazil

  • Centro Integrado de Pesquisa Clinica

    RECRUITING

    São José do Rio Preto, 15090-000, Brazil

  • Centro de Investigaciones Clínicas Viña del Mar (CIC)

    ACTIVE_NOT_RECRUITING

    Viña del Mar, 2520000, Chile

  • Chang Bing Show Chwan Memorial Hospital

    RECRUITING

    Changhua, 710, Taiwan

  • Chang Gung Memorial Hospital - Chiayi

    RECRUITING

    Chiayi County, 61363, Taiwan

  • Clinica Universitaria De Navarra

    RECRUITING

    Pamplona, 31008, Spain

  • Clínica de Nefrología, Urología y Enfermedades Cardiovasculares

    RECRUITING

    Santa Fe, 3000, Argentina

  • Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum

    RECRUITING

    Debrecen, 4004, Hungary

  • Dunedin Hospital

    ACTIVE_NOT_RECRUITING

    Dunedin, 9016, New Zealand

  • Ege Üniversitesi

    ACTIVE_NOT_RECRUITING

    Bornova, 35040, Turkey (Türkiye)

  • Fakultni Nemocnice Ostrava

    RECRUITING

    Ostrava, 708 52, Czechia

  • Fakultni Nemocnice Plzen

    RECRUITING

    Pilsen, 305 99, Czechia

  • Fakultni nemocnice Brno

    RECRUITING

    Brno, 62500, Czechia

  • Fakultni nemocnice Hradec Kralove

    RECRUITING

    Hradec Králové, 500 05, Czechia

  • Fakultni nemocnice Kralovske Vinohrady

    RECRUITING

    Prague, 10034, Czechia

  • First Affiliated Hosp of College of Med, Zhejiang University

    RECRUITING

    Hangzhou, 310003, China

  • Florida Cancer Specialists

    RECRUITING

    Fort Myers, Florida, 33916-2233, United States

  • Florida Cancer Specialists East

    RECRUITING

    West Palm Beach, Florida, 33401, United States

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, 200032, China

  • Fundação Pio XII - Hospital de Câncer de Barretos

    RECRUITING

    Barretos, 14784400, Brazil

  • Gazi University Faculty of Medicine

    ACTIVE_NOT_RECRUITING

    Ankara, 6500, Turkey (Türkiye)

  • Gemeinschaftspraxis für Hämatologie und Onkologie (Gefos)

    ACTIVE_NOT_RECRUITING

    Dortmund, 44309, Germany

  • Guangxi Medical University Affiliated Tumor Hospital

    RECRUITING

    Nanning, 530021, China

  • HOPE Centre

    ACTIVE_NOT_RECRUITING

    Leicester, LE1 5WW, United Kingdom

  • Hadassah Medical Center

    RECRUITING

    Jerusalem, 9112001, Israel

  • Hainan General Hospital

    ACTIVE_NOT_RECRUITING

    Haikou, 570311, China

  • Hanusch Krankenhaus

    ACTIVE_NOT_RECRUITING

    Vienna, 1140, Austria

  • Hematology Oncology Clinic

    ACTIVE_NOT_RECRUITING

    Baton Rouge, Louisiana, 70809, United States

  • Hemocentro Unicamp

    RECRUITING

    Campinas, 13083-878, Brazil

  • Hopital de L'Enfant Jesus

    RECRUITING

    Québec, G1J 1Z4, Canada

  • Hopital de la Pitie Salpetriere

    RECRUITING

    Paris, 75651, France

  • Hospital BP

    RECRUITING

    São Paulo, 01321-001, Brazil

  • Hospital Clinic de Barcelona

    ACTIVE_NOT_RECRUITING

    Barcelona, 08036, Spain

  • Hospital Costa Del Sol

    RECRUITING

    Marbella, 29600, Spain

  • Hospital De Navarra

    RECRUITING

    Pamplona, 31008, Spain

  • Hospital Duran i Reynals

    ACTIVE_NOT_RECRUITING

    L'Hospitalet de Llobregat, 08908, Spain

  • Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

    RECRUITING

    Curitiba, 81520060, Brazil

  • Hospital Privado De Comunidad

    ACTIVE_NOT_RECRUITING

    Mar del Plata, 7600, Argentina

  • Hospital Santa Marcelina

    RECRUITING

    São Paulo, 08270-120, Brazil

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 8035, Spain

  • Hospital Universitario Infanta Leonor-INTERNAL MED

    RECRUITING

    Madrid, 28031, Spain

  • Hospital Universitario Marqués de Valdecilla

    RECRUITING

    Santander, 39008, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    RECRUITING

    Majadahonda, 28222, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, 41009, Spain

  • Hospital Uopeccan - Centro de Pesquisa Clinica

    RECRUITING

    Cascavel, 85806-300, Brazil

  • Hospital da Clinicas da Faculdade de Medicina da USP

    RECRUITING

    São Paulo, 05403-000, Brazil

  • Hospital de Clínicas de Ribeirão Preto

    RECRUITING

    Ribeirão Preto, 14051-140, Brazil

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, 08025, Spain

  • Hunan Cancer Hospital

    ACTIVE_NOT_RECRUITING

    Changsha, 410013, China

  • Hôpital de Pontchaillou

    RECRUITING

    Rennes, 35033, France

  • IRCCS Ospedale San Raffaele

    RECRUITING

    Milan, 20132, Italy

  • Inje Univ Busan Paik Hospital

    RECRUITING

    Busan, 47392, South Korea

  • Inmunocel

    ACTIVE_NOT_RECRUITING

    Santiago, 7580206, Chile

  • Instituto do Câncer - Hospital São Vicente de Paulo

    RECRUITING

    Passo Fundo, 99010090, Brazil

  • Istanbul University Istanbul Medicine Faculty

    RECRUITING

    Faith, 34732, Turkey (Türkiye)

  • Istituto Europeo di Oncologia

    RECRUITING

    Milan, 20141, Italy

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    RECRUITING

    Meldola, 47014, Italy

  • Jiangxi Provincial Cancer Hospital

    ACTIVE_NOT_RECRUITING

    Nanchang, 330029, China

  • KO-MED Centra Kliniczne

    ACTIVE_NOT_RECRUITING

    Biała Podlaska, 21500, Poland

  • Kelsey Research Foundation

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77025, United States

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

    ACTIVE_NOT_RECRUITING

    Lublin, 20-081, Poland

  • Koo Foundation Sun Yan-Sen Cancer Center

    RECRUITING

    Taipei, 112, Taiwan

  • Kumamoto University Hospital

    ACTIVE_NOT_RECRUITING

    Kumamoto, 860-8556, Japan

  • Lumi Research

    RECRUITING

    Kingwood, Texas, 77339, United States

  • Markusovszky Egyetemi Oktatokorhaz

    ACTIVE_NOT_RECRUITING

    Szombathely, 9700, Hungary

  • Medical Oncology Associates, PS

    RECRUITING

    Spokane, Washington, 99208, United States

  • Middlemore Clinical Trials

    RECRUITING

    Papatoetoe, 2025, New Zealand

  • Momentum Clinical Research

    RECRUITING

    Newtown, 6242, New Zealand

  • MultiCare Health System Institute for Research and Innovation

    ACTIVE_NOT_RECRUITING

    Spokane, Washington, 99218, United States

  • National Cheng-Kung Uni. Hosp.

    ACTIVE_NOT_RECRUITING

    Tainan, 704, Taiwan

  • One Clinical Research

    ACTIVE_NOT_RECRUITING

    Nedlands, 6009, Australia

  • Onkologische Gemeinschaftspraxis / BAG

    RECRUITING

    Dresden, 01307, Germany

  • Pacific Cancer Medical Center, Inc

    RECRUITING

    Anaheim, California, 92801, United States

  • Policlinico Sant'Orsola Malpighi

    ACTIVE_NOT_RECRUITING

    Bologna, 40138, Italy

  • Pratia MCM Krakow

    RECRUITING

    Krakow, 30-510, Poland

  • Pratia Onkologia Katowice

    RECRUITING

    Katowice, 40519, Poland

  • Prisma Health Cancer Institute

    ACTIVE_NOT_RECRUITING

    Greenville, South Carolina, 29605, United States

  • Royal Victoria Hospital-Montreal

    TERMINATED

    Montreal, H3A 1A1, Canada

  • Samsung Medical Center

    ACTIVE_NOT_RECRUITING

    Seoul, 06351, South Korea

  • Sarah Cannon Research Institute SCRI

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Singleton Hospital

    RECRUITING

    Swansea, SA2 8QA, United Kingdom

  • Sociedad de Investigaciones Médicas Limitada

    RECRUITING

    Temuco, 4780000, Chile

  • Southern Medical University Nanfang Hospital

    RECRUITING

    Guangzhou, 510515, China

  • St Bartholomew's Hospital

    ACTIVE_NOT_RECRUITING

    London, EC1A 7BE, United Kingdom

  • St. Vincent Frontier Cancer Center

    RECRUITING

    Billings, Montana, 59102, United States

  • Stanford School of Medicine-Cancer Clinical Trials Office

    RECRUITING

    Palo Alto, California, 94305, United States

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, 510060, China

  • Szpital Uniwersytecki nr 1 im. Antoniego Jurasza

    RECRUITING

    Bydgoszcz, 85-168, Poland

  • TOI Clinical Research

    RECRUITING

    Cerritos, California, 90703, United States

  • Tel Aviv Sourasky Medical Center

    ACTIVE_NOT_RECRUITING

    Tel Aviv, 6423906, Israel

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

    RECRUITING

    Seocho-Gu, 06591, South Korea

  • The Fourth Affiliated Hospital Zhejiang University School of Medicine

    ACTIVE_NOT_RECRUITING

    Yiwu, 322000, China

  • The Perth Blood Institute

    RECRUITING

    West Perth, 6005, Australia

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    ACTIVE_NOT_RECRUITING

    Hangzhou, 310009, China

  • The Second Hospital of Anhui Medical University

    RECRUITING

    Hefei, 231200, China

  • The Second Xiangya Hospital of Central South University

    ACTIVE_NOT_RECRUITING

    Changsha, 410011, China

  • Tianjin Medical University General Hospital

    ACTIVE_NOT_RECRUITING

    Tianjin, 300052, China

  • Tulane Cancer Center Office of Clinical Research

    ACTIVE_NOT_RECRUITING

    New Orleans, Louisiana, 70112, United States

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    ACTIVE_NOT_RECRUITING

    Wuhan, 430022, China

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

    ACTIVE_NOT_RECRUITING

    Dresden, 01307, Germany

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    RECRUITING

    Leuven, 3000, Belgium

  • Universitätsklinikum Ulm

    ACTIVE_NOT_RECRUITING

    Ulm, 89075, Germany

  • Uniwersytecki Szpital Kliniczny Klinika

    RECRUITING

    Wroclaw, 50-367, Poland

  • Uniwersyteckie Centrum Kliniczne

    RECRUITING

    Gdansk, 80-952, Poland

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

    RECRUITING

    Botucatu, 18618-687, Brazil

  • VITAZ

    RECRUITING

    Sint-Niklaas, B-9100, Belgium

  • Virginia Cancer Institute

    RECRUITING

    Richmond, Virginia, 23230, United States

  • Vseobecna fakultni nemocnice v Praze

    RECRUITING

    Prague, 12808, Czechia

  • Waikato Hospital

    ACTIVE_NOT_RECRUITING

    Hamilton, 3204, New Zealand

  • Western Health, Sunshine Hospital

    ACTIVE_NOT_RECRUITING

    St Albans, 3021, Australia

  • Wu Han Tongji Hospital

    ACTIVE_NOT_RECRUITING

    Wuhan, 430030, China

  • Yamagata University Hospital

    RECRUITING

    Yamagata, 990-9585, Japan

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