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New pill combo aims to outperform current standard in CLL

NCT ID NCT07277231

Disease control Sponsor: BeOne Medicines 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 11, 2026 · Updated 9 times

Summary

This phase 3 trial is testing whether a new combination of two oral drugs, sonrotoclax and zanubrutinib, works better than the current standard combination (venetoclax plus acalabrutinib) for people with untreated chronic lymphocytic leukemia (CLL). About 500 adults who have not received prior CLL treatment will be randomly assigned to one of the two pill regimens. The main goals are to see how long participants live without their cancer progressing and to measure how deeply the cancer is suppressed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sonrotoclax and zanubrutinib (oral drugs)
What this could lead to
If successful, this could offer a new fixed-duration oral combination therapy for people with untreated CLL, potentially improving how long they live without their cancer getting worse.
What could go wrong
This is an early-stage comparison against an already approved regimen, so it may not prove superior. Side effects from the drug combination are possible, and results may not apply to all CLL patients.

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 500 people

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

Started

Jan 2026

Expected to finish

Nov 2031

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: * Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment * Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2 * Measurable disease by Computer Tomography/Magnetic Resonance Imaging * Adequate bone marrow and organ function Exclusion Criteria: * Previous systemic treatment for CLL * Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation * Known central nervous system involvement * History of confirmed progressive multifocal leukoencephalopathy (PML) * Uncontrolled hypertension or clinically significant cardiovascular disease Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia

As listed by the trial registrant

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

Chronic lymphocytic leukemia

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    114 sites in 17 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Affiliated Hospital of Nantong University

    RECRUITING

    Nantong, Jiangsu, 201203, China

  • Albert Schweitzer Ziekenhuis

    RECRUITING

    Dordrecht, 3318 AT, Netherlands

  • Aou Careggi, Servizio Sanitario Toscana

    RECRUITING

    Florence, 50134, Italy

  • Asan Medical Center

    RECRUITING

    SongpaGu, Seoul Teugbyeolsi, 05505, South Korea

  • Atrium Health Levine Cancer Institute (Lci)

    RECRUITING

    Charlotte, North Carolina, 28204-2990, United States

  • Auckland City Hospital

    RECRUITING

    Auckland, 1023, New Zealand

  • Austin Health

    RECRUITING

    Heidelberg, Victoria, VIC 3084, Australia

  • Azienda Ospedaliera Di Padova

    RECRUITING

    Padova, 35128, Italy

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, 20162, Italy

  • Bc Cancer Victoria

    RECRUITING

    Victoria, British Columbia, V8R 6V5, Canada

  • Blacktown Cancer and Haematology Centre

    RECRUITING

    Blacktown, New South Wales, NSW 2148, Australia

  • Cabrini Hospital Malvern

    RECRUITING

    Malvern, Victoria, VIC 3144, Australia

  • Centre Hospitalier Le Mans

    RECRUITING

    Le Mans, 72037, France

  • Centre Leon Berard

    RECRUITING

    Lyon, 69373, France

  • Centre de Lutte Contre Le Cancer Institut Bergonie

    RECRUITING

    Bordeaux, 33076, France

  • Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

    RECRUITING

    Porto Alegre, 90110-270, Brazil

  • Centrum Fur Haematologie Und Onkologie Bethanien

    RECRUITING

    Frankfurt am Main, 60389, Germany

  • Chao Family Comprehensive Cancer Center

    RECRUITING

    Orange, California, 92868-3201, United States

  • Chu Clermont Ferrand Therapie Cellulaire and Hematolo

    RECRUITING

    ClermontFerrand, 63100, France

  • Chu Montpellier Hopital Saint Eloi

    RECRUITING

    Montpellier, 34090, France

  • Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)

    RECRUITING

    Québec, Quebec, G1J 1Z4, Canada

  • City of Hope National Medical Center

    RECRUITING

    Duarte, California, 91010-3012, United States

  • Ciusss Nim Hscm

    RECRUITING

    Montreal, Quebec, H4J 1C5, Canada

  • Ciusss de Lestrie Chus

    RECRUITING

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Coltea Clinical Hospital

    RECRUITING

    Bucharest, 30171, Romania

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Concord Repatriation General Hospital

    RECRUITING

    Concord, New South Wales, NSW 2139, Australia

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215-5418, United States

  • Donauisar Klinikum Deggendorf Klinik Fur Onkologie Und Hamatologie

    RECRUITING

    Deggendorf, 94469, Germany

  • Dunedin Hospital

    RECRUITING

    Dunedin, 9016, New Zealand

  • Ensino E Terapia de Inovacao Clinica Amo Etica

    RECRUITING

    Salvador, 41950-640, Brazil

  • Fakultni Nemocnice Brno

    RECRUITING

    Brno, 625 00, Czechia

  • Fakultni Nemocnice Hradec Kralove

    RECRUITING

    Hradec Králové, 500 03, Czechia

  • Fakultni Nemocnice Olomouc

    RECRUITING

    Olomouc, 77900, Czechia

  • Fakultni Nemocnice Ostrava

    RECRUITING

    Ostrava, 708 00, Czechia

  • Fakultni Nemocnice Plzen

    RECRUITING

    PLZE, 323 00, Czechia

  • First Affiliated Hospital of Kunming Medical University

    RECRUITING

    Kunming, Yunnan, 650032, China

  • Flevoziekenhuis

    RECRUITING

    Almere Stad, 1315 RA, Netherlands

  • Fondazione Policlinico Universitario Agostino Gemelli

    RECRUITING

    Roma, 00168, Italy

  • Fred Hutchinson Cancer Research Center

    RECRUITING

    Seattle, Washington, 98109-4433, United States

  • Geho Munster

    RECRUITING

    Münster, 48153, Germany

  • Genesiscare North Shore

    RECRUITING

    St Leonards, New South Wales, NSW 2065, Australia

  • Guizhou Provincial Peoples Hospital

    RECRUITING

    Guiyang, Guizhou, 550002, China

  • Hagaziekenhuis

    RECRUITING

    Sgravenhage, 2545 AA, Netherlands

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, Heilongjiang, 150000, China

  • Health New Zealand Canterbury

    RECRUITING

    Christchurch, 8011, New Zealand

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450000, China

  • Hopital Claude Huriez Chu Lille

    RECRUITING

    Lille, 59000, France

  • Hospital Clinico Universitario Virgen de La Arrixaca

    RECRUITING

    Murcia, 30120, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    RECRUITING

    Majadahonda, 28222, Spain

  • Hospital Universitario Virgen de Las Nieves

    RECRUITING

    Granada, 18014, Spain

  • Huntsman Cancer Institute

    RECRUITING

    Salt Lake City, Utah, 84112-5550, United States

  • Institute of Hematology and Hospital of Blood Disease

    RECRUITING

    Tianjin, Tianjin Municipality, 300020, China

  • Instituto Dor de Pesquisa E Ensino Distrito Federal

    RECRUITING

    Brasília, 70390140, Brazil

  • Instituto Dor de Pesquisa E Ensino Sao Paulo

    RECRUITING

    São Paulo, 01401-004, Brazil

  • Institutul Clinic Fundeni

    RECRUITING

    Bucureti, 022328, Romania

  • Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca

    RECRUITING

    ClujNapoca, 400015, Romania

  • Irccs Azienda Ospedaliero Universitaria Bologna

    RECRUITING

    Bologna, 40138, Italy

  • Iuc Toulouse Oncopole

    RECRUITING

    Toulouse, 31100, France

  • Jewish General Hospital

    RECRUITING

    Montreal, Quebec, QC H3t 1E2, Canada

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Juravinski Cancer Centre

    RECRUITING

    Hamilton, Ontario, L8V 5C2, Canada

  • Karolinska Universitetssjukhuset Solna

    RECRUITING

    Stockholm, 171 76, Sweden

  • Kings College Hospital

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Klinikum St Elisabeth Straubing Gmbh Mvz Klinikum Straubing Gmbh

    RECRUITING

    Straubing, 94315, Germany

  • Mayo Clinic Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224-1865, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905-0001, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226-3522, United States

  • Midwestern Regional Medical Center

    RECRUITING

    Zion, Illinois, 60099-2676, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612-9496, United States

  • Monash Health

    RECRUITING

    Clayton, Victoria, VIC 3168, Australia

  • Mount Sinai Medical Center Braman Comprehensive Cancer Center

    RECRUITING

    Miami, Florida, 33140, United States

  • Norfolk and Norwich University Hospitals Nhs Foundation Trust

    RECRUITING

    Norwich, NR4 7UY, United Kingdom

  • North Shore Hospital

    RECRUITING

    Auckland, 0622, New Zealand

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Ochsner Clinic Foundation

    RECRUITING

    New Orleans, Louisiana, 70121-2429, United States

  • Oncology Associates of Oregon Willamette Valley Cancer Center

    RECRUITING

    Eugene, Oregon, 97401, United States

  • Ospedale San Raffaele

    RECRUITING

    Milan, 20132, Italy

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100730, China

  • Pratia McM Krakow

    RECRUITING

    Krakow, 30-727, Poland

  • Pratia Onkologia Katowice

    RECRUITING

    Katowice, 40-519, Poland

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, Queensland, QLD 4102, Australia

  • Queen Elizabeth Hospital

    RECRUITING

    Birmingham, B15 2TH, United Kingdom

  • Rocky Mountain Cancer Centers (Williams) Usor

    RECRUITING

    Aurora, Colorado, 80012-5405, United States

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200025, China

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    RECRUITING

    SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

  • Shandong Provincial Hospital

    RECRUITING

    Jinan, Shandong, 250000, China

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    RECRUITING

    Chengdu, Sichuan, 610071, China

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    RECRUITING

    São Paulo, 05652-900, Brazil

  • St Jamess University Hospital

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • Stanford Cancer Institute

    RECRUITING

    Palo Alto, California, 94304-2205, United States

  • Sun Yat Sen University Cancer Center Huangpu Branch

    RECRUITING

    Guangzhou, Guangdong, 510555, China

  • Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny

    RECRUITING

    Brzozów, 36-200, Poland

  • Texas Oncology Tyler

    RECRUITING

    Tyler, Texas, 75702-7522, United States

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, VIC 3004, Australia

  • The Catholic University of Korea, Seoul St Marys Hospital

    RECRUITING

    SeochoGu, Seoul Teugbyeolsi, 06591, South Korea

  • The First Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, 630014, China

  • The First Affiliated Hospital of Fujian Medical University

    RECRUITING

    Fuzhou, Fujian, 350005, China

  • The First Affiliated Hospital of Guangxi Medical University

    RECRUITING

    Nanning, Guangxi, 530021, China

  • The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

    RECRUITING

    Hangzhou, Zhejiang, 310002, China

  • The Second Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • The Second Affiliated Hospital of Xian Jiaotong University

    RECRUITING

    Xi'an, Shaanxi, 710004, China

  • The Second Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, 410011, China

  • University Hospitals Dorset Royal Bournemouth Hospital

    RECRUITING

    Bournemouth, BH7 7DW, United Kingdom

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu

    RECRUITING

    Wroclaw, 50-367, Poland

  • Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie

    RECRUITING

    Lublin, 20-090, Poland

  • Upmc Hillman Cancer Center(Univ of Pittsburgh)

    RECRUITING

    Pittsburgh, Pennsylvania, 15232-1309, United States

  • Vseobecna Fakultni Nemocnice V Praze

    RECRUITING

    Prague, 10000, Czechia

  • Wellington Regional Hospital (Ccdhb)

    RECRUITING

    Wellington, 6021, New Zealand

  • Zhujiang Hospital of Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, 510000, China

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