AzTrials
AzTrials

Mantle Cell LymphomaPhase 3NCT06742996

A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)

A Phase 3 study testing Sonrotoclax and Zanubrutinib in people with Mantle Cell Lymphoma and B Cell Lymphoma, run by BeOne Medicines at 145 sites in 17 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 goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mantle Cell Lymphoma, B Cell Lymphoma
What is being tested?
Sonrotoclax and Zanubrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
145 sitesin 17 countries
Study dates
5 Mar 2025to 30 Mar 2032
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

  • Histologically locally confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)
  • Ability to provide archival or fresh tumor tissue for retrospective central confirmation of MCL diagnosis
  • Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator
  • Relapsed or refractory disease after the last line of therapy
  • Measurable disease defined as ≥ 1 nodal lesion that is > 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is > 1 cm in longest diameter
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
  • Adequate organ function

Who cannot join

  • Prior therapy with B-cell lymphoma-2 inhibitor (BCL2i)
  • Prior therapy with BTK degraders
  • Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi. Participants with refractory disease to BTKi therapy or relapse attributed to failure of BTKi therapy are ineligible.
  • Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
  • Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug
  • Known central nervous system involvement by lymphoma
Show all 9Show fewer
  • Clinically significant cardiovascular disease
  • History of stroke or intracranial hemorrhage within 6 months before first dose of study drug
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

145 sites in 17 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

145 sites in 17 countries

United States41 sites, 41 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109-1382

    Recruiting

  • The University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

    Recruiting

  • Our Lady of the Lake Hospital

    Baton Rouge, Louisiana, 70808-4365

    Recruiting

  • University of Alabama At Birmingham Hospital

    Birmingham, Alabama, 35294-0004

    Recruiting

  • Dana Farber Cancer Institute Longwood Medical Center

    Boston, Massachusetts, 02215-5418

    Recruiting

  • Atrium Health Levine Cancer Institute (Lci)

    Charlotte, North Carolina, 28204-2990

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, 22908-0817

    Recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60607

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637-1443

    Recruiting

  • University Hospitals

    Cleveland, Ohio, 44106-1716

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195-0001

    Recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210-1280

    Recruiting

  • Ohio Health Research Institute

    Columbus, Ohio, 43214-3907

    Recruiting

  • Duke University

    Durham, North Carolina, 27710

    Recruiting

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46804

    Recruiting

  • Ucsf Fresno

    Fresno, California, 93701

    Recruiting

  • Virgina Cancer Specialists

    Gainesville, Virginia, 20155-3257

    Recruiting

  • Nebraska Cancer Specialists St Francis Grand Island

    Grand Island, Nebraska, 68803

    Recruiting

  • The Cancer and Hematology Centers

    Grand Rapids, Michigan, 49503-2563

    Recruiting

  • Hattiesburg Hematology and Oncology Clinic

    Hattiesburg, Mississippi, 39401-7233

    Recruiting

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Recruiting

  • Md Anderson Cancer Center

    Houston, Texas, 77030-3907

    Recruiting

  • Kaiser Permanente Southern California

    Irvine, California, 92618-3734

    Recruiting

  • University of Wisconsin

    Madison, Wisconsin, 53792-0001

    Recruiting

  • Tennessee Oncology Nashville St Thomas Midtown Clinic

    Nashville, Tennessee, 37205

    Recruiting

  • Tennessee Oncology

    Nashville, Tennessee, 37205

    Recruiting

  • Yale University Yale Cancer Center

    New Haven, Connecticut, 06520-8028

    Recruiting

  • Memorial Sloan Kettering Cancer Center Mskcc

    New York, New York, 10065-6800

    Recruiting

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130-2042

    Recruiting

  • The Valley Hospital, Inc

    Paramus, New Jersey, 07652

    Recruiting

  • Memorial Cancer Institute, Memorial Healthcare System

    Pembroke Pines, Florida, 33026-4119

    Recruiting

  • Vcu Massey Cancer Center

    Richmond, Virginia, 23298-5026

    Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905-0001

    Recruiting

  • Texas Oncology Austin Midtown

    Round Rock, Texas, 78681-4019

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110-1010

    Recruiting

  • University of Arizona Cancer Center

    Tucson, Arizona, 85724-0001

    Recruiting

  • Northwest Cancer Specialist, Pc(Us Oncology Research)

    Vancouver, Washington, 98684-6930

    Recruiting

  • Mission Cancer and Blood

    Waukee, Iowa, 50263

    Recruiting

  • McGlinn Cancer Institute

    West Reading, Pennsylvania, 19611-2143

    Recruiting

  • Cleveland Clinic Florida

    Weston, Florida, 33331-3609

    Recruiting

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina, 27157

    Recruiting

Other trials in United States

China19 sites, 17 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Recruiting

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, Sichuan, 610071

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 630014

    Recruiting

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

    Hangzhou, Zhejiang, 310002

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

    Recruiting

  • Linyi Cancer Hospital

    Linyi, Shandong, 276001

    Recruiting

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330029

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Recruiting

  • The Affiliated Hospital of Qingdao University Branch West Coast

    Qingdao, Shandong, 266555

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

    Recruiting

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Recruiting

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

    Wuhan, Hubei, 430022

    Active, not recruiting

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

    Wuhan, Hubei, 430030

    Active, not recruiting

  • Shaanxi Provincial Peoples Hospital

    Xi'an, Shaanxi, 710068

    Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Recruiting

Other trials in China

Japan18 sites, 18 recruiting

  • Institute of Science Tokyo Hospital

    Bunkyoku, Tokyo, 113-8519

    Recruiting

  • Chiba Cancer Center

    Chiba, Chiba, 260-8717

    Recruiting

  • Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital

    Hiroshima, Hiroshima, 730-8619

    Recruiting

  • Kagoshima University Hospital

    Kagoshima, Kagoshima-ken, 890-8520

    Recruiting

  • Kobe City Medical Center General Hospital

    KobeShi, Hyōgo, 650-0047

    Recruiting

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya, Saitama, 503-8502

    Recruiting

  • Kurashiki Central Hospital

    Kurashikishi, Okayama-ken, 710-8602

    Recruiting

  • Matsuyama Red Cross Hospital

    Matsuyama, Ehime, 790 8524

    Recruiting

  • Aichi Cancer Center Hospital Clinical Oncology

    Nagoya, Aichi-ken, 464-8681

    Recruiting

  • Ogaki Municipal Hospital

    Ōgaki, Gifu, 503-8502

    Recruiting

  • National Hospital Organization Okayama Medical Center

    Okayama, Okayama-ken, 701-1192

    Recruiting

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, 545-8586

    Recruiting

  • Osaka Red Cross Hospital

    Osakashi, Osaka, 543-8555

    Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

    Recruiting

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

    Recruiting

  • Toyohashi Municipal Hospital

    Toyohashishi, Aichi-ken, 441-8570

    Recruiting

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

    Recruiting

  • Yokohama Municipal Citizens Hospital

    Yokohama, 221-0855

    Recruiting

Other trials in Japan

Brazil10 sites, 1 recruiting

  • Fundacao Pio Xii Hospital de Amor de Barretos

    Barretos, 14.784-400

    Active, not recruiting

  • Hospital Felicio Rocho

    Belo Horizonte, 30110-068

    Active, not recruiting

  • Universidade de Campinas Centro de Hematologia E Hemoterapia

    Campinas, 13083-878

    Active, not recruiting

  • Fundacao Universidade de Caxias Do Sul

    Caxias do Sul, 95070-560

    Active, not recruiting

  • Hospital Erasto Gaertner

    Curitiba, 81520-060

    Active, not recruiting

  • Instituto Joinvilense de Hematologia E Oncologia

    Joinville, 89201-260

    Active, not recruiting

  • Hospital de Clinicas de Porto Alegre

    Porto AlegreRS, 900350-903

    Active, not recruiting

  • Hospital Do Cancer de Pernambuco

    Recife, 50040-000

    Active, not recruiting

  • Hcfmusp Pesquisa Clinica Do Servico de Hematologia E Terapia Celular

    São Paulo, 05403-010

    Active, not recruiting

  • Hospital Santa Rita de Cassia Afecc

    Vitória, 29043-260

    Recruiting

Other trials in Brazil

Germany7 sites, 7 recruiting

  • Klinikum Chemnitz Ggmbh

    Chemnitz, 09116

    Recruiting

  • Universitatsklinikum Frankfurt

    Frankfurt am Main, 60596

    Recruiting

  • Universitatsklinikum Halle

    Halle, 06120

    Recruiting

  • Dept of Medicine Iii, University Hospitallmu

    München, 81377

    Recruiting

  • Stauferklinikum Schwabisch Gmund Kliniken Ostalb

    Mutlangen, 73557

    Recruiting

  • Diakonie Klinikum Jung Stilling Krankenhaus

    Siegen, 57074

    Recruiting

  • Robert Bosch Krankenhaus, Abteilung Hamatologie, Onkologie Und Palliativmedizin

    Stuttgart, 70376

    Recruiting

Other trials in Germany

United Kingdom7 sites, 7 recruiting

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

    Recruiting

  • The Royal Bournemouth and Christchurch Hospitals Nhs Foundation

    Bournemouth, BH7 7DW

    Recruiting

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

    Recruiting

  • Oxford University Hospitals Nhs Trust Churchill Hospital

    Headington, OX3 7LE

    Recruiting

  • University College Hospital

    London, NW1 2PG

    Recruiting

  • Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral, CH63 4JY

    Recruiting

  • Derriford Hospital

    Plymouth, PL6 8DH

    Recruiting

Other trials in United Kingdom

South Korea6 sites

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi, 06351

    Active, not recruiting

  • The Catholic University of Korea, Seoul St Marys Hospital

    SeochoGu, Seoul Teugbyeolsi, 06591

    Active, not recruiting

  • Pusan National University Hospital

    Seogu, Busan Gwang'Yeogsi, 49241

    Active, not recruiting

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080

    Active, not recruiting

  • Asan Medical Center

    SongpaGu, Seoul Teugbyeolsi, 05505

    Active, not recruiting

  • The Catholic University of Korea, Yeouido St Marys Hospital

    Yeongdeungpo-gu, Seoul Teugbyeolsi, 07345

    Active, not recruiting

Other trials in South Korea

Australia5 sites

  • Sunshine Coast Hospital and Health Service

    Birtinya, Queensland, QLD 4575

    Active, not recruiting

  • Box Hill Hospital

    Box Hill, Victoria, VIC 3128

    Active, not recruiting

  • Monash Health

    Clayton, Victoria, VIC 3168

    Active, not recruiting

  • Rockingham Hospital

    Cooloongup, Western Australia, WA 6168

    Active, not recruiting

  • Perth Blood Institute

    West Perth, Western Australia, WA 6005

    Active, not recruiting

Other trials in Australia

Italy5 sites

  • Policlinico Sorsola Malpighi, Aou Di Bologna

    Bologna, 40138

    Active, not recruiting

  • Ospedale Vito Fazzi, Asl Lecce

    Lecce, 73100

    Active, not recruiting

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst

    Meldola, 47014

    Active, not recruiting

  • Azienda Sanitaria Universitaria Giuliano Isontina

    Trieste, 34129

    Active, not recruiting

  • Centroricerche Cliniche Di Verona Srl

    Verona, 37134

    Active, not recruiting

Other trials in Italy

New Zealand5 sites

  • North Shore Hospital

    Auckland, 0622

    Active, not recruiting

  • Christchurch Hospital

    Christchurch, 8011

    Active, not recruiting

  • Dunedin Hospital

    Dunedin, 9016

    Active, not recruiting

  • Tauranga Hospital

    Tauranga, 3112

    Active, not recruiting

  • Wellington Regional Hospital (Ccdhb)

    Wellington, 6021

    Active, not recruiting

Other trials in New Zealand

Poland5 sites

  • Pratia McM Krakow

    Krakow, 30-727

    Active, not recruiting

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

    Lodz, 93-510

    Active, not recruiting

  • Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie

    Lublin, 20-090

    Active, not recruiting

  • Aidport Sp Z O O

    Skorzewo, 60-185

    Active, not recruiting

  • Dolnoslaskie Centrum Onkologii, Pulmonologii I Hematologii

    Wroclaw, 53-439

    Active, not recruiting

Other trials in Poland

Argentina4 sites, 1 recruiting

  • Hospital Aleman

    Caba, 1425

    Recruiting

  • FUNDALEU

    Caba, CP1114

    Active, not recruiting

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma Buenos Aires, 1413

    Active, not recruiting

  • Hospital Universitario de Cordoba

    Córdoba, X5000HUA

    Active, not recruiting

Other trials in Argentina

France4 sites, 2 recruiting

  • Chu Montpellier Hopital Saint Eloi

    Montpellier, 34090

    Recruiting

  • Centre Hospitalier Universitaire Nantes Hotel Dieu

    Nantes, 44000

    Active, not recruiting

  • Chu Hopital Lyon Sud

    PierreBenite, 69495

    Active, not recruiting

  • Chu Tours Hopital Bretonneau

    Tours, 37000

    Recruiting

Other trials in France

Spain4 sites

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Active, not recruiting

  • Ico H Duran I Reynals

    Barcelona, 08907

    Active, not recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

    Completed

  • H Puerta de Hierro Majadahonda

    Majadahonda, 28222

    Active, not recruiting

Other trials in Spain

Turkey (Türkiye)3 sites

  • Etlik City Hospital

    Ankara, 06170

    Active, not recruiting

  • Antalya Memorial Hospital

    Dokuma, 07025

    Active, not recruiting

  • Kocaeli Universitesi Tip Fakultesi

    Kocaeli, 41380

    Active, not recruiting

Other trials in Turkey (Türkiye)

Austria1 site

  • Uk St Poelten

    Sankt Pölten, 3100

    Active, not recruiting

Other trials in Austria

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 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma

The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.

Read the detailed description

Mantle cell lymphoma (MCL) is a rare, aggressive type of B-cell lymphoma. B-cells are white blood cells that help fight infections. Lymphoma is a cancer in the lymphatic system. Sometimes this type of cancer can come back after treatment (relapse), or it does not respond to treatment or stops responding to treatment (refractory).

Sonrotoclax is a drug which blocks a protein called B-cell lymphoma-2 (Bcl-2). Zanubrutinib works by blocking a protein called Bruton tyrosine kinase (BTK). Bcl-2 and BTK help certain blood cancer cells live and grow. By blocking Bcl-2 and BTK, sonrotoclax and zanubrutinib may slow or stop cancer cell growth and help them die.

The purpose of this study is to test if sonrotoclax plus zanubrutinib is safe and if it works better in adults with R/R MCL compared to zanubrutinib plus placebo. The main goal is to compare how long participants live without their disease getting worse. The study will also evaluate side effects and overall safety.

This study has two treatment groups. Participants will be randomly assigned (by chance) to receive sonrotoclax plus zanubrutinib or zanubrutinib plus placebo. All study treatments will be taken by mouth. Placebo is a pill that looks like the study drug but has no active ingredient. Participants and the study doctor will not know what treatment group the participant is assigned to during the study, unless there is an urgent medical need.

The study will enroll approximately 300 adults with R/R MCL at multiple centers worldwide.

The overall time to participate in this study is up to approximately 7 years. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and tumor imaging tests.

Note: 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
Sonrotoclax, Zanubrutinib, Placebo
Keywords
mantle cell lymphoma, MCL, relapsed/refractory mantle cell lymphoma, sonrotoclax, BGB-11417
Medical subject headings
Lymphoma, Mantle-Cell, Lymphoma, B-Cell

What participants receive

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

  • SonrotoclaxDrug

    Also called BGB-11417

    Administered orally

  • ZanubrutinibDrug

    Also called Brukinsa, BGB-3111

    Administered orally

  • PlaceboDrug

    Administered orally

Study groups in NCT06742996
Study groupRoleWhat they receive
Arm A: sonrotoclax plus zanubrutinibExperimentalSonrotoclax and zanubrutinib will be administered in combination.
Receives: Drug: Sonrotoclax; Drug: Zanubrutinib
Arm B: placebo plus zanubrutinibPlacebo comparatorPlacebo and zanubrutinib will be administered in combination.
Receives: Drug: Zanubrutinib; Drug: Placebo

What is being measured

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

  1. Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC)

    PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.

    Measured: Approximately 41 months

Secondary outcomes (10)

  1. Overall Survival (OS)

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

    Measured: Approximately 92 months

  2. PFS as assessed by investigator (INV)

    PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.

    Measured: Approximately 58 months

  3. Overall Response Rate (ORR) as assessed by BIRC and by INV

    ORR is defined as the percentage of participants who achieved a best overall response of partial response (PR) or complete response (CR), per Lugano 2014 criteria.

    Measured: Approximately 58 months

  4. Duration of Response (DOR) as assessed by BIRC and by INV

    DOR is defined as the time from the first qualifying response to the date of progression or death, whichever occurs first.

    Measured: Approximately 58 months

  5. Complete Response Rate (CRR) as assessed by BIRC and by INV

    CRR is defined as the percentage of participants who achieved a best overall response of CR.

    Measured: Approximately 58 months

  6. Time to first response as assessed by BIRC and by INV

    Time to first response is defined as time from the date of randomization to first response.

    Measured: Approximately 58 months

  7. Time to initiation of new anticancer therapy

    Time to initiation of new anticancer therapy is defined as time from the date of randomization to the date of initiation of new anticancer therapy.

    Measured: Approximately 58 months

  8. Health-Related Quality of Life (HRQoL) as Assessed by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Non-Hodgkin Lymphoma High Grade Module 29 (EORTC-QLQ-NHL-HG29)

    Patient-reported symptom burden, neuropathy, and physical condition/fatigue as measured by the EORTC-QLQ-NHL-HG29 questionnaire. The EORTC-QLQ-NHL-HG29 is the NHL-aggressive module of QLQ-C30; and it consists of 5 scales: Symptom burden due to disease and/or treatment (7 items), Neuropathy (2 items), Physical condition/Fatigue (5 items), Emotional impacts (4 items), and Worries/Fears health and functioning (11 items). Items are rated using a 4-point response scale ("not at all," "a little," "quite a bit," and "very much"). A higher score for all the multi-item scales and items represents a higher level of symptomatology or problems.

    Measured: Approximately 58 months

  9. Health-Related Quality of Life (HRQoL) as Assessed by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)

    Patient-reported global health status (GHS), role, and physical function as measured by the EORTC-QLQ-C30 questionnaire. The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 =Not at all (best) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best).

    Measured: Approximately 58 months

  10. Number of participants with treatment-emergent adverse events (TEAEs)

    Number of participants with TEAEs, including laboratory values, vital signs, electrocardiogram results, and physical examination findings, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.

    Measured: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 58 months

Timeline

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

  1. First posted19 Dec 2024
  2. Study start5 Mar 2025
  3. Primary completion31 Aug 2028 (estimated)
  4. Study completion30 Mar 2032 (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
Double blind
Who is masked
Participant, Investigator
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06742996
Sponsor's protocol ID
BGB-11417-302
Other IDs
2024-515593-27-00, CTR20250207
Status last verified
Oct 2026
First submitted
16 Dec 2024
Last updated
29 Oct 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 Sonrotoclax and Zanubrutinib in people with Mantle Cell Lymphoma and B Cell Lymphoma, run by BeOne Medicines at 145 sites in 17 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 7 inclusion and 9 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 145 sites in United States, China, Japan, Brazil, Germany and 12 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. Some participants in this study may receive a placebo. 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) as assessed by Blinded Independent Review Committee (BIRC) (time frame: Approximately 41 months). 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 NCT06742996.

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 29 Oct 2026.

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