AzTrials
AzTrials

Chronic Lymphocytic LeukemiaPhase 3NCT06973187

A Study to Evaluate the Safety and Efficacy of Tacabrutideg (BGB-16673) Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

A Phase 3 study testing Tacabrutideg and Pirtobrutinib in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by BeOne Medicines at 217 sites in 24 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of tacabrutideg alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tacabrutideg and Pirtobrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
217 sitesin 24 countries
Study dates
4 Sep 2025to 17 Apr 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL criteria
  • Previously received treatment for CLL/SLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi.
  • Participants with SLL must have measurable disease by computed tomography/magnetic resonance imaging, defined as ≥ 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular diameters.

Who cannot join

  • Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation.
  • History of known bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
  • History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug
  • Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or noncovalent Bruton tyrosine kinase inhibitor (ncBTKi).
  • Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by CLL/SLL
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

217 sites in 24 countries. Contact the study team or a site near you to ask about taking part.

Study Director contact

1-877-828-5568

clinicaltrials@beonemed.com

217 sites in 24 countries

United States49 sites, 49 recruiting

  • Our Lady of the Lake Hospital

    Baton Rouge, Louisiana, 70808-4365

    Recruiting

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809-3738

    Recruiting

  • University of Alabama At Birmingham Hospital

    Birmingham, Alabama, 35294-0004

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215-5418

    Recruiting

  • University of North Carolina At Chapel Hill

    Chapel Hill, North Carolina, 27514-4220

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29402-0955

    Recruiting

  • Atrium Health Levine Cancer Institute (Lci)

    Charlotte, North Carolina, 28204-2990

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637-1443

    Recruiting

  • Dayton Physician Network

    Dayton, Ohio, 45415

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201-2013

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27705-3976

    Recruiting

  • Titan Health Partners Llc Dba Astera Cancer Care

    East Brunswick, New Jersey, 08816-4096

    Recruiting

  • John Theurer Cancer Center Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Recruiting

  • Md Anderson Cancer Center

    Houston, Texas, 77030-3907

    Recruiting

  • Kaiser Permanente Southern California

    Irvine, California, 92618-3734

    Recruiting

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224-1865

    Recruiting

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256

    Recruiting

  • Gunderson Health System

    La Crosse, Wisconsin, 54601-5467

    Recruiting

  • University of California San Diego (Ucsd) Moores Cancer Center

    La Jolla, California, 92093-1503

    Recruiting

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720-3302

    Recruiting

  • UCLA Department of Medicine Hematologyoncology

    Los Angeles, California, 90095-3075

    Recruiting

  • Mount Sinai Medical Center Braman Comprehensive Cancer Center

    Miami, Florida, 33140

    Recruiting

  • Tennessee Oncology, Pllc Nashville

    Nashville, Tennessee, 37203

    Recruiting

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121-2429

    Recruiting

  • Columbia University Medical Center

    New York, New York, 10032

    Recruiting

  • Weill Cornell Medical College Newyork Presbyterian Hospital

    New York, New York, 10065-4870

    Recruiting

  • Memorial Sloan Kettering Cancer Center Mskcc

    New York, New York, 10065-6800

    Recruiting

  • Christiana Care

    Newark, Delaware, 19713-2055

    Recruiting

  • Kaiser Permanente Oakland Medical Center

    Oakland, California, 94611

    Recruiting

  • Texas Oncology Palestine Cancer Center

    Palestine, Texas, 75801-6981

    Recruiting

  • Stanford Cancer Institute

    Palo Alto, California, 94304-2205

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2434

    Recruiting

  • Mayo Clinic Phoenix

    Phoenix, Arizona, 85054-4502

    Recruiting

  • Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia)

    Roanake, Virginia, 24014

    Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905-0001

    Recruiting

  • University of Rochester

    Rochester, New York, 14642-0001

    Recruiting

  • Kaiser Permanente Roseville Medical Center

    Roseville, California, 95661

    Recruiting

  • Kaiser Permanente San Francisco Medical Center Oncology

    San Francisco, California, 94115

    Recruiting

  • Kaiser Permanente Santa Clara Medical Center Oncologyhematology

    Santa Clara, California, 95051

    Recruiting

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-4433

    Recruiting

  • Summit Cancer Centers

    Spokane, Washington, 99208-1129

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110-1010

    Recruiting

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

    Recruiting

  • Kaiser Permanente Northern California

    Vallejo, California, 94589-2441

    Recruiting

  • Kaiser Permanente Walnut Creek Medical Center

    Walnut Creek, California, 94596

    Recruiting

  • Medstar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007-2113

    Recruiting

  • Mission Cancer and Blood

    Waukee, Iowa, 50263

    Recruiting

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205-2003

    Recruiting

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina, 27157

    Recruiting

Other trials in United States

China34 sites, 34 recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Recruiting

  • Binzhou Medical University Hospital

    Binzhou, Shandong, 256603

    Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Recruiting

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, Sichuan, 610071

    Recruiting

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning, 116023

    Recruiting

  • Dazhou Central Hospital

    Dazhou, Sichuan, 635099

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

    Recruiting

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Recruiting

  • Guizhou Provincial Peoples Hospital

    Guiyang, Guizhou, 550002

    Recruiting

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150007

    Recruiting

  • Jiangmen Central Hospital

    Jiangmen, Guangdong, 529030

    Recruiting

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

    Recruiting

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

    Recruiting

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, 646099

    Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

    Recruiting

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 201203

    Recruiting

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, 315010

    Recruiting

  • Renji Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200000

    Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

    Recruiting

  • The Fourth Hospital of Hebei Medical University East Branch

    Shijiazhuang, Hebei, 050035

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Recruiting

  • Taian City Central Hospital

    Taian, Shandong, 271099

    Recruiting

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032

    Recruiting

  • Institute of Hematology and Hospital of Blood Disease

    Tianjin, Tianjin Municipality, 300020

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technologychegu Branch

    Wuhan, Hubei, 430056

    Recruiting

  • Wuxi Peoples Hospital

    Wuxi, Jiangsu, 214023

    Recruiting

  • The Second Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shaanxi, 710004

    Recruiting

  • Qinghai University Affiliated Hospital

    Xining, Qinghai, 810001

    Recruiting

  • Xuchang Central Hospitalluminghu Branch

    Xuchang, Henan, 461000

    Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    Recruiting

Other trials in China

Japan18 sites, 18 recruiting

  • Tokyo Metropolitan Komagome Hospital

    Bunkyoku, Tokyo, 113-8677

    Recruiting

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295

    Recruiting

  • Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital

    Hiroshima, Hiroshima, 730-8619

    Recruiting

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya, Saitama, 503-8502

    Recruiting

  • Cancer Institute Hospital of Jfcr

    Kotoku, Tokyo, 135-8550

    Recruiting

  • Kumamoto University Hospital

    Kumamoto, Kumamoto, 860-8556

    Recruiting

  • Japanese Red Cross Kyoto Daini Hospital

    Kyotoshi, Kyoto, 602-8026

    Recruiting

  • Matsuyama Red Cross Hospital

    Matsuyama, Ehime, 790 8524

    Recruiting

  • Aichi Cancer Center Hospital Clinical Oncology

    Nagoya, Aichi-ken, 464-8681

    Recruiting

  • Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital

    Nakamuraku, Aichi-ken, 453-8511

    Recruiting

  • Kochi Medical School Hospital

    Nankoku, Kochi, 783-8505

    Recruiting

  • Oita Prefectural Hospital

    Ōita, Oita Prefecture, 870-8511

    Recruiting

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558

    Recruiting

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, 545-8586

    Recruiting

  • Kindai University Hospital

    Sakai, Osaka, 590-0197

    Recruiting

  • Aiiku Hospital

    Sapporo, Hokkaido, 064-0804

    Recruiting

  • National Hospital Organization (Nho) Disaster Medical Center

    Tachikawashi, Tokyo, 190-0014

    Recruiting

  • Yamagata University Hospital

    Yamagata, Yamagata, 990-9585

    Recruiting

Other trials in Japan

Australia14 sites, 14 recruiting

  • Flinders Medical Centre

    Bedford PK, South Australia, SA 5042

    Recruiting

  • Pindara Private Hospital

    Benowa, Queensland, QLD 4217

    Recruiting

  • Sunshine Coast Hospital and Health Service

    Birtinya, Queensland, QLD 4575

    Recruiting

  • Concord Repatriation General Hospital

    Concord, New South Wales, NSW 2139

    Recruiting

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, VIC 3065

    Recruiting

  • Peninsula Private Hospital

    Frankston, Victoria, VIC 3199

    Recruiting

  • Austin Health

    Heidelberg, Victoria, VIC 3084

    Recruiting

  • St George Private Hospital

    Kogarah, New South Wales, 2217

    Recruiting

  • Cabrini Hospital Malvern

    Malvern, Victoria, VIC 3144

    Recruiting

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, VIC 3000

    Recruiting

  • The Alfred Hospital

    Melbourne, Victoria, VIC 3004

    Recruiting

  • Linear Clinical Research

    Nedlands, Western Australia, WA 6009

    Recruiting

  • John Flynn Private Hospital

    Tugun, Queensland, QLD 4224

    Recruiting

  • Westmead Private Hospital

    Westmead, New South Wales, 2145

    Recruiting

Other trials in Australia

Germany9 sites, 9 recruiting

  • St Josef Hospital Klinikum Der Ruhr Universitat Bochum

    Bochum, 44791

    Recruiting

  • Universitatsklinikum Bonn

    Bonn, 53127

    Recruiting

  • Uniklinik Koeln (Aoer)

    Cologne, 50937

    Recruiting

  • Gemeinschaftspraxis Fur Hamatologie Und Onkologie Dortmund

    Dortmund, 44309

    Recruiting

  • Stadtisches Klinikum Karlsruhe

    Karlsruhe, 76133

    Recruiting

  • Mvz Fur Hamatologie Und Onkologie Lubeckgmbh

    Lübeck, 23562

    Recruiting

  • Robert Bosch Krankenhaus, Abteilung Hamatologie, Onkologie Und Palliativmedizin

    Stuttgart, 70376

    Recruiting

  • Universitaetsklinikum Ulm

    Ulm, 89081

    Recruiting

  • Gemeinschaftspraxis Fuer Haematologie Und Onkologie Westerstede

    Westerstede, 26655

    Recruiting

Other trials in Germany

Brazil8 sites, 8 recruiting

  • Centro de Pesquisa Clinica Dom Bosco Ltda

    Araçatuba, 16015-150

    Recruiting

  • Hospital Felicio Rocho

    Belo Horizonte, 30110-068

    Recruiting

  • Ictr Instituto Do Cancer E Transplante de Curitiba

    Curitiba, 80510-130

    Recruiting

  • Hospital de Clinicas de Goiania Ufg

    Goiânia, 74605-020

    Recruiting

  • Inca Instituto Nacional de Cancer

    Rio de Janeiro, 20231-050

    Recruiting

  • Ensino E Terapia de Inovacao Clinica Amo Etica

    Salvador, 41950-640

    Recruiting

  • Hospital Nove de Julho Dasa

    São Paulo, 01409-001

    Recruiting

  • Hcfmusp Hospital Das Clinicas Da Faculdade de Medicina Da Universidade de Sao Paulo

    São Paulo, 05403-010

    Recruiting

Other trials in Brazil

France8 sites, 8 recruiting

  • Centre de Lutte Contre Le Cancer Institut Bergonie

    Bordeaux, 33076

    Recruiting

  • Hopital Estaing

    ClermontFerrand, 63100

    Recruiting

  • Centre Hospitalier Universitaire Nantes Hotel Dieu

    Nantes, 44000

    Recruiting

  • Hopital Saint Louis

    Paris, 75010

    Recruiting

  • Centre Henri Becquerel

    Rouen, 76038

    Recruiting

  • Iuc Toulouse Oncopole

    Toulouse, 31100

    Recruiting

  • Chu Tours Hopital Bretonneau

    Tours, 37000

    Recruiting

  • Chu Nancy Hopital Brabois

    VandoeuvrelesNancy, 54511

    Recruiting

Other trials in France

Poland8 sites, 8 recruiting

  • Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii

    Gdansk, 80-219

    Recruiting

  • Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach

    Kielce, 25-734

    Recruiting

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

    Lodz, 93-513

    Recruiting

  • Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie

    Lublin, 20-081

    Recruiting

  • Szpital Kliniczny Mswia Z Warmisko Mazurskim Centrum Onkologii

    Olsztyn, 10-228

    Recruiting

  • Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu

    Torun, 87-100

    Recruiting

  • Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie

    Warsaw, 02-781

    Recruiting

  • Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu

    Wroclaw, 50-367

    Recruiting

Other trials in Poland

Belgium7 sites, 7 recruiting

  • Institut Jules Bordet

    Anderlecht, 1070

    Recruiting

  • UZ GENT

    Ghent, 9000

    Recruiting

  • Az Groeninge Campus Loofstraat

    Kortrijk, 8500

    Recruiting

  • Chc Montlegia

    Liège, 4000

    Recruiting

  • Chu de Liege

    Liège, 4000

    Recruiting

  • Az Sint Maarten

    Mechelen, 2800

    Recruiting

  • Chu Ucl Namur

    Yvoir, 5530

    Recruiting

Other trials in Belgium

Israel7 sites, 7 recruiting

  • Bnai Zion Medical Center

    Haifa, 31048

    Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

    Recruiting

  • Hadassah University Hospital Ein Kerem

    Jerusalem, 91120

    Recruiting

  • Meir Medical Center

    KfarSava, 4428164

    Recruiting

  • Rabin Medical Center

    Petah Tikva, 49100

    Recruiting

  • Sheba Medical Center

    Ramat Gan, 5262100

    Recruiting

  • Sourasky Tel Aviv Medical Center

    Tel Aviv, 6423906

    Recruiting

Other trials in Israel

Spain7 sites, 7 recruiting

  • Ico Badalona

    Badalona, 08916

    Recruiting

  • Hospital Universitario de Burgos

    Burgos, 09006

    Recruiting

  • Hospital Universitario de Gran Canaria Dr Negrin

    Las Palmas de Gran Canaria, 35010

    Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

    Recruiting

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222

    Recruiting

  • Hospital Universitari Son Espases

    Palma de Mallorca, 07120

    Recruiting

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

    Recruiting

Other trials in Spain

Netherlands6 sites, 6 recruiting

  • Albert Schweitzer Ziekenhuis

    Dordrecht, 3318 AT

    Recruiting

  • Catharina Hospital

    EJ Eindhoven, 5623

    Recruiting

  • Groene Hart Hospital

    Gouda, 2803

    Recruiting

  • University of Medical Center Groningen (Umcg)

    Groningen, 9713 GZ

    Recruiting

  • Canisius Wilhelmina Ziekenhuis

    Nijmegen, 6532 SZ

    Recruiting

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

    Recruiting

Other trials in Netherlands

South Korea6 sites, 6 recruiting

  • Gyeongsang National University Hospital

    Jinju, Gyeongsangnam-do, 52727

    Recruiting

  • The Catholic University of Korea, Seoul St Marys Hospital

    SeochoGu, Seoul Teugbyeolsi, 06591

    Recruiting

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi, 03722

    Recruiting

  • Pusan National University Hospital

    Seogu, Busan Gwang'Yeogsi, 49241

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

    Recruiting

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080

    Recruiting

Other trials in South Korea

United Kingdom6 sites, 6 recruiting

  • University Hospitals Sussex Nhs Foundation Trust

    Brighton, BN2 5BE

    Recruiting

  • Kent and Canterbury Hospital

    Canterbury, CT1 3NG

    Recruiting

  • Norfolk and Norwich University Hospitals Nhs Foundation Trust

    Norwich, NR4 7UY

    Recruiting

  • Oxford University Hospitals Nhs Foundation Trust

    Oxford, OX42PG

    Recruiting

  • Spire Leeds Healthcare Spire Leeds Hospital

    Roundhay, LS8 1NT

    Recruiting

  • Salisbury Foundation Trust

    Salisbury, SP2 8BJ

    Recruiting

Other trials in United Kingdom

Austria5 sites, 5 recruiting

  • Medical University Graz

    Graz, 8036

    Recruiting

  • Medizinische Universitatsklinik Innsbruck

    Innsbruck, 6020

    Recruiting

  • Ordensklinikum Linz Gmbh Elisabethinen

    Linz, 4020

    Recruiting

  • Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg

    Salzburg, 5020

    Recruiting

  • Uk St Poelten

    Sankt Pölten, 3100

    Recruiting

Other trials in Austria

Argentina4 sites, 4 recruiting

  • FUNDALEU

    Caba, CP1114

    Recruiting

  • Sanatorio Allende

    Córdoba, X5000BFB

    Recruiting

  • Centro Oncologico de Integracion Regional (Coir)

    Mendoza, M5500

    Recruiting

  • Hospital Privado de Rosario

    Rosario, 60430-277

    Recruiting

Other trials in Argentina

Italy4 sites, 4 recruiting

  • Policlinico Sorsola Malpighi, Aou Di Bologna

    Bologna, 40138

    Recruiting

  • Ospedale San Raffaele

    Milan, 20132

    Recruiting

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162

    Recruiting

  • Azienda Ospedaliera Di Padova

    Padova, 35128

    Recruiting

Other trials in Italy

Mexico4 sites, 4 recruiting

  • Centro de Investigacion Clinica Gramel

    México, 3720

    Recruiting

  • Christus Latam Hub Center of Excellence and Innovation Sc

    Monterrey, 64000

    Recruiting

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, 68020

    Recruiting

  • Centro Hemato Oncologico Privado de Toluca

    Toluca, 50120

    Recruiting

Other trials in Mexico

New Zealand3 sites, 3 recruiting

  • North Shore Hospital

    Auckland, 0622

    Recruiting

  • Tauranga Hospital

    Tauranga, 3112

    Recruiting

  • Wellington Regional Hospital (Ccdhb)

    Wellington, 6021

    Recruiting

Other trials in New Zealand

Romania3 sites, 3 recruiting

  • Coltea Clinical Hospital

    Bucharest, 30171

    Recruiting

  • Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca

    ClujNapoca, 400015

    Recruiting

  • Institutul Regional de Oncologie Iasi

    Iași, 700483

    Recruiting

Other trials in Romania

Singapore2 sites, 2 recruiting

  • Singapore General Hospital

    Singapore, 168582

    Recruiting

  • Tan Tock Seng Hospital Haematology

    Singapore, 308433

    Recruiting

Other trials in Singapore

Sweden2 sites, 2 recruiting

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 46

    Recruiting

  • Karolinska Universitetssjukhuset Solna

    Stockholm, 171 76

    Recruiting

Other trials in Sweden

Switzerland2 sites, 2 recruiting

  • Inselspital Bern (Inselspital, Universitatsspital Bern)

    Bern, 3010

    Recruiting

  • Universitatsspital Zurich

    Zurich, 8091

    Recruiting

Other trials in Switzerland

Puerto Rico1 site, 1 recruiting

  • Auxilio Mutuo Cancer Center

    San Juan, 00917

    Recruiting

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

The purpose of this study is to evaluate the efficacy and safety of tacabrutideg alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).

Read the detailed description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Being tested
Tacabrutideg, Pirtobrutinib
Keywords
Noncovalent Bruton tyrosine kinase inhibitor, Bruton tyrosine kinase-targeted protein degrader
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TacabrutidegDrug

    Also called BGB-16673

    Tacabrutideg will be administered orally

  • PirtobrutinibDrug

    Also called Jaypirca

    Pirtobrutinib will be administered orally

Study groups in NCT06973187
Study groupRoleWhat they receive
Arm A: TacabrutidegExperimentalParticipants will receive tacabrutideg orally.
Receives: Drug: Tacabrutideg
Arm B: PirtobrutinibActive comparatorParticipants will receive pirtobrutinib orally.
Receives: Drug: Pirtobrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS) per Independent Review Committee (IRC)

    PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with chronic lymphocytic leukemia (CLL) and Lugano classification for participants with small lymphocytic lymphoma (SLL).

    Measured: Up to approximately 3 years

Secondary outcomes (8)

  1. Overall Survival (OS)

    OS is defined as the time from the date of randomization to the date of death due to any cause.

    Measured: Up to approximately 3 years

  2. PFS per Investigator (INV)

    PFS per INV is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by investigator using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with CLL and Lugano classification for participants with SLL.

    Measured: Up to approximately 3 years

  3. Overall Response Rate (ORR) per IRC and INV

    ORR is defined as the percentage of participants with a best overall response of complete response, complete response with incomplete bone marrow recovery, nodular partial remission, or partial response, as assessed by the investigator and IRC using modified 2018 iwCLL criteria for patients with CLL and Lugano classification for patients with SLL.

    Measured: Up to approximately 3 years

  4. Rate of Partial Response with Lymphocytosis (PR-L) or Higher per IRC and INV

    The rate of PR-L or higher is defined as the percentage of participants with a best overall response of complete response, complete response with incomplete bone marrow recovery, nodular partial remission, partial response, or PR-L.

    Measured: Up to approximately 3 years

  5. Duration of Response (DOR) per IRC and INV

    DOR is defined as the time from initial response to disease progression or death, whichever occurs first.

    Measured: Up to approximately 3 years

  6. Time to Next Anti-CLL/SLL Treatment (TTNT)

    TTNT is defined as the time from the date of randomization to the date of next anti-CLL/SLL treatment.

    Measured: Up to approximately 3 years

  7. Number of Participants with Adverse Events (AEs)

    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory abnormalities.

    Measured: Up to approximately 3 years

  8. Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire EORTC IL409

    EORTC IL409 consists of a set of 19 questions derived from the EORTC quality of life questionnaire core 30 (QLQ-C30) and its CLL module CLL17. The EORTC IL409 includes questions on global health status (GHS)/quality of life, physical functioning, role functioning, physical condition/fatigue, and symptom burden.Higher scores in GHS and functional scales and lower scores in symptom scales indicate better health-related quality of life.

    Measured: Baseline and up to approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2025
  2. Study start4 Sep 2025
  3. Primary completion17 Apr 2028 (estimated)
  4. Study completion17 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06973187
Sponsor's protocol ID
BGB-16673-304
Other IDs
2025-522860-34-00, 2025
Status last verified
Sep 2026
First submitted
7 May 2025
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tacabrutideg and Pirtobrutinib in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by BeOne Medicines at 217 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 217 sites in United States, China, Japan, Australia, Germany and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Director (1-877-828-5568, clinicaltrials@beonemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) per Independent Review Committee (IRC) (time frame: Up to approximately 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06973187.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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