AzTrials
AzTrials

CLLPhase 3CaDAnCe-302NCT06846671

A Study of Tacabrutideg (BGB-16673) Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors

A Phase 3 study testing Tacabrutideg, Bendamustine and Idelalisib in people with CLL and Chronic Lymphocytic Leukemia, run by BeOne Medicines at 132 sites in 14 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 investigate the efficacy and safety of tacabrutideg compared with investigator's choice (idelalisib plus rituximab [for CLL only] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
CLL, Chronic Lymphocytic Leukemia
What is being tested?
Tacabrutideg, Bendamustine and Idelalisib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
132 sitesin 14 countries
Study dates
10 Apr 2025to 14 Feb 2030
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 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
  • Previously received treatment for CLL/SLL with both a BTKi and a BCL2i.
  • Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI)
  • Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
  • Adequate liver function
  • Adequate blood clotting function

Who cannot join

  • Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
  • Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months
  • Known central nervous system involvement
  • Prior exposure to any BTK protein degraders
  • Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy
  • Clinically significant cardiovascular disease
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

132 sites in 14 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

132 sites in 14 countries

United States29 sites, 29 recruiting

  • Emory University Winship Cancer Institute

    Atlanta, Georgia, 30322-1013

    Recruiting

  • Northside Cancer Center

    Atlanta, Georgia, 30342

    Recruiting

  • Rocky Mountain Cancer Centers (Williams) Usor

    Aurora, Colorado, 80012-5405

    Recruiting

  • Our Lady of the Lake Hospital

    Baton Rouge, Louisiana, 70808-4365

    Recruiting

  • American Oncology Partners of Maryland Pa

    Bethesda, Maryland, 20817-7847

    Recruiting

  • St Vincent Frontier Cancer Center

    Billings, Montana, 59102-6746

    Recruiting

  • St Lukes Center For Cancer Care

    Chesterfield, Missouri, 63017

    Recruiting

  • University Hospitals

    Cleveland, Ohio, 44106-1716

    Recruiting

  • Dayton Physician Network

    Dayton, Ohio, 45415

    Recruiting

  • Oncology Associates of Oregon Willamette Valley Cancer Center

    Eugene, Oregon, 97401

    Recruiting

  • Florida Oncology and Hematology

    Fort Myers, Florida, 33912

    Recruiting

  • Intermountain Health Lutheran Hospital Cancer Center of Colorado

    Golden, Colorado, 80401

    Recruiting

  • Corewell Health the Michigan Cancer Consortium

    Grand Rapids, Michigan, 49503-2560

    Recruiting

  • Baptist Md Anderson Cancer Center

    Jacksonville, Florida, 32207-8432

    Recruiting

  • St Bernards Medical Center

    Jonesboro, Arkansas, 72401

    Recruiting

  • UCLA Department of Medicine Hematologyoncology

    Los Angeles, California, 90095-3075

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455-0341

    Recruiting

  • Memorial Sloan Kettering Cancer Center Mskcc

    New York, New York, 10065-6800

    Recruiting

  • Oncology Hematology West, Pc Dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68130-2042

    Recruiting

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

    Recruiting

  • Scripps Prebys Cancer Center

    San Diego, California, 92103-2106

    Recruiting

  • New York Cancer and Blood Specialists

    Shirley, New York, 11967

    Recruiting

  • Oncology Hematology Associates

    Springfield, Missouri, 65807-5288

    Recruiting

  • Baylor Scott and White Health

    Temple, Texas, 76508-0001

    Recruiting

  • Texas Oncology Tyler

    Tyler, Texas, 75702-7522

    Recruiting

  • Optum Medical Care, Pc

    Westbury, New York, 11590-5119

    Recruiting

  • Cleveland Clinic Florida

    Weston, Florida, 33331-3609

    Recruiting

  • Pih Health Whittier Hospital

    Whittier, California, 90602

    Recruiting

  • Cancer Care Associates of York

    York, Pennsylvania, 17403-5049

    Recruiting

Other trials in United States

Japan19 sites, 19 recruiting

  • Hyogo Prefectural Amagasaki General Medical Center

    AmagasakiCity, Hyōgo, 660-8550

    Recruiting

  • Tokyo Metropolitan Komagome Hospital

    Bunkyoku, Tokyo, 113-8677

    Recruiting

  • Chiba Cancer Center

    Chiba, Chiba, 260-8717

    Recruiting

  • Kansai Medical University Hospital

    Hirakata, Osaka, 573-1191

    Recruiting

  • Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital

    Hiroshima, Hiroshima, 730-8619

    Recruiting

  • Kagoshima University Hospital

    Kagoshima, Kagoshima-ken, 890-8520

    Recruiting

  • Saitama Medical Center

    Kawagoeshi, Saitama, 350-8550

    Recruiting

  • Kumamoto University Hospital

    Kumamoto, 860-8556

    Recruiting

  • Kurashiki Central Hospital

    Kurashikishi, Okayama-ken, 710-8602

    Recruiting

  • University Hospital, Kyoto Prefectural Univ of Medicine

    KyotoShi, Kyoto, 602-8566

    Recruiting

  • Nho Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

    Recruiting

  • Aichi Cancer Center Hospital Clinical Oncology

    Nagoya, Aichi-ken, 464-8681

    Recruiting

  • Niigata University Medical and Dental Hospital

    Niigata, Niigata, 951-8520

    Recruiting

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192

    Recruiting

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586

    Recruiting

  • Kindai University Hospital

    Sakai, Osaka, 590-0197

    Recruiting

  • Aiiku Hospital

    Sapporo, Hokkaido, 064-0804

    Recruiting

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

    Recruiting

  • Ntt Medical Center Tokyo

    Shinagawaku, Tokyo, 141-0022

    Recruiting

Other trials in Japan

Brazil14 sites, 14 recruiting

  • CETUS

    Belo Horizonte, 30110-022

    Recruiting

  • Hospital Sirio Libanes Brasilia

    Brasília, 70200-730

    Recruiting

  • Hospital Erasto Gaertner

    Curitiba, 81520-060

    Recruiting

  • Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen)

    Florianópolis, 88020-210

    Recruiting

  • Instituto Joinvilense de Hematologia E Oncologia

    Joinville, 89201-260

    Recruiting

  • Complexo Hospitalar de Niteroi

    Niterói, 24020-096

    Recruiting

  • Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

    Porto Alegre, 90110-270

    Recruiting

  • Hospital Sao Lucas Dasa Oncologia

    Rio de Janeiro, 22061-080

    Recruiting

  • Oncoclinicas Rio de Janeiro Sa

    Rio de Janeiro, 22250-040

    Recruiting

  • Hospital Sao Rafael (Rede Dor)

    Salvador, 41253-190

    Recruiting

  • Instituto Dor de Pesquisa E Ensino Sao Paulo

    São Paulo, 01401-004

    Recruiting

  • Instituto Brasileiro de Controle Do Cancer

    São Paulo, 04014-002

    Recruiting

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05652-900

    Recruiting

  • Hospital Santa Rita de Cassia Afecc

    Vitória, 29043-260

    Recruiting

Other trials in Brazil

Germany12 sites, 12 recruiting

  • Universitatsklinikum Augsburg

    Augsburg, 86156

    Recruiting

  • Praxis Am Volkspark

    Berlin, 10715

    Recruiting

  • Klinikum Chemnitz Ggmbh

    Chemnitz, 09116

    Recruiting

  • Universitatsklinikum Essen (Aor)

    Essen, 45122

    Recruiting

  • Centrum Fur Haematologie Und Onkologie Bethanien

    Frankfurt am Main, 60389

    Recruiting

  • Universitatsklinikum Freiburg I Br Klinik Fur Innere Medizin I

    Freiburg im Breisgau, 79106

    Recruiting

  • Universitatsklinikum Hamburg Eppendorf

    Hamburg, 20251

    Recruiting

  • Universitatsklinikum Heidelberg

    Heidelberg, 69120

    Recruiting

  • Universitatsklinikum Des Saarlandes

    Homburg, 66421

    Recruiting

  • Invo Institut Fur Versorgungsforschung in Der Onkologie

    Koblenz, 56068

    Recruiting

  • Universitaetsklinikum Leipzig Aor

    Leipzig, 04103

    Recruiting

  • Universitatsklinikum Munster Medizinische Klinik A

    Münster, 48149

    Recruiting

Other trials in Germany

Italy9 sites, 9 recruiting

  • Irccs Istituto Tumori Giovanni Paolo Ii

    Bari, 70124

    Recruiting

  • Aou Careggi, Servizio Sanitario Toscana

    Florence, 50134

    Recruiting

  • Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122

    Recruiting

  • Ospedale San Raffaele

    Milan, 20132

    Recruiting

  • Azienda Ospedaliera Universitaria Federico Ii

    Naples, 80131

    Recruiting

  • Aou Maggiore Della Carita

    Novara, 28100

    Recruiting

  • Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi

    Pavia, 27100

    Recruiting

  • Ospedale Santa Maria Della Misericordia

    Perugia, 6129

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168

    Recruiting

Other trials in Italy

Australia8 sites, 8 recruiting

  • Flinders Medical Centre

    Bedford PK, South Australia, SA 5042

    Recruiting

  • Concord Repatriation General Hospital

    Concord, New South Wales, NSW 2139

    Recruiting

  • Gosford Hospital

    Gosford, New South Wales, NSW 2250

    Recruiting

  • The Alfred Hospital

    Melbourne, Victoria, VIC 3004

    Recruiting

  • Port Macquarie Base Hospital

    Port Macquarie, New South Wales, NSW 2444

    Recruiting

  • Prince of Wales Hospital

    Randwick, New South Wales, NSW 2031

    Recruiting

  • Toowoomba Hospital

    Toowoomba, Queensland, QLD 4350

    Recruiting

  • Perth Blood Institute

    West Perth, Western Australia, WA 6005

    Recruiting

Other trials in Australia

South Korea7 sites, 7 recruiting

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi, 06351

    Recruiting

  • Chonnam National University Hwasun Hospital

    HwasunGun, Jeonnam-Gwangju S.M. City, 58128

    Recruiting

  • National Cancer Center (Korea)

    IlsandongGu GoyangSi, Gyeonggi-do, 10408

    Recruiting

  • Kyungpook National University Hospital

    Junggu, Daegu Gwang'yeogsi, 41944

    Recruiting

  • The Catholic University of Korea, Seoul St Marys Hospital

    SeochoGu, Seoul Teugbyeolsi, 06591

    Recruiting

  • Dong A University Hospital

    Seogu, Busan Gwang'yeogsi, 49201

    Recruiting

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080

    Recruiting

Other trials in South Korea

Argentina6 sites, 6 recruiting

  • Hospital Aleman

    Caba, 1425

    Recruiting

  • CEMIC

    Caba, C1431

    Recruiting

  • FUNDALEU

    Caba, CP1114

    Recruiting

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma Buenos Aires, 1413

    Recruiting

  • Instituto Alexander Fleming (Iaf)

    Ciudad Autonoma Buenos Aires, 1426

    Recruiting

  • Cice 9 de Julio Sanatorio 9 de Julio

    San Miguel de Tucumán, 4000

    Recruiting

Other trials in Argentina

Canada6 sites, 6 recruiting

  • Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre

    Greenfield Park, Quebec, J4V 2H1

    Recruiting

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

    Recruiting

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

    Recruiting

  • Jewish General Hospital

    Montreal, Quebec, QC H3t 1E2

    Recruiting

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

    Recruiting

  • Unite de Recherche Clinique Du Cisss Des Laurentides

    SaintJerome, Quebec, J7Z 5T3

    Recruiting

Other trials in Canada

Poland6 sites, 6 recruiting

  • Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny

    Brzozów, 36-200

    Recruiting

  • Pratia Onkologia Katowice

    Katowice, 40-519

    Recruiting

  • Pratia McM Krakow

    Krakow, 30-727

    Recruiting

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

    Lodz, 93-513

    Recruiting

  • Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie

    Lublin, 20-090

    Recruiting

  • Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu

    Wroclaw, 50-367

    Recruiting

Other trials in Poland

United Kingdom6 sites, 6 recruiting

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

    Recruiting

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

    Recruiting

  • The Royal Bournemouth and Christchurch Hospitals Nhs Foundation

    Bournemouth, BH7 7DW

    Recruiting

  • University College Hospital

    London, NW1 2PG

    Recruiting

  • Royal Marsden Hospital

    London, SW3 6JJ

    Recruiting

  • Southampton General Hospital

    Southampton, SO16 6YD

    Recruiting

Other trials in United Kingdom

Turkey (Türkiye)5 sites, 5 recruiting

  • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    Ankara, 06200

    Recruiting

  • Gazi University

    Ankara, 6500

    Recruiting

  • Dokuz Eylul University

    Balçova, 35330

    Recruiting

  • Antalya Memorial Hospital

    Dokuma, 07025

    Recruiting

  • Sakarya Training and Research Hospital

    Sakarya, 54100

    Recruiting

Other trials in Turkey (Türkiye)

Czechia4 sites, 4 recruiting

  • Fakultni Nemocnice Brno

    Brno, 625 00

    Recruiting

  • Fakultni Nemocnice Hradec Kralove

    Hradec Králové, 500 03

    Recruiting

  • Fakultni Nemocnice Ostrava

    Ostrava, 708 00

    Recruiting

  • Vseobecna Fakultni Nemocnice V Praze

    Prague, 10000

    Recruiting

Other trials in Czechia

Netherlands1 site, 1 recruiting

  • Amsterdam Umc Vu Mc

    Amsterdam, 1081 HV

    Recruiting

Other trials in Netherlands

About this study

Official title: A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors

The purpose of this study is to investigate the efficacy and safety of tacabrutideg compared with investigator's choice (idelalisib plus rituximab [for CLL only] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).

Read the detailed description

Chronic lymphocytic leukemia is a type of blood cancer that affects people around the world. People with CLL suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. They have shorter life expectancy compared to healthy people. There is an urgent need for new treatment to prolong life and control disease-related symptoms.

In this study, participants with relapsed/refractory (R/R) CLL who were previously exposed to a BTKi and a BCL2i will receive tacabrutideg or the investigator's choice of idelalisib plus rituximab (for CLL only) or bendamustine plus rituximab or venetoclax plus rituximab retreatment. The main purpose of this study is to compare the length of time that participants live without their CLL or SLL worsening between those participants who receive tacabrutideg versus the investigator's choice of treatment (idelalisib plus rituximab or bendamustine plus rituximab, or venetoclax plus rituximab).

Approximately 250 participants will be included in this study around the world. Participants will be randomly allocated to receive either tacabrutideg or the investigator's choice of treatment.

"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, Bendamustine, Idelalisib, Rituximab, Venetoclax
Keywords
CLL
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

    Administered orally

  • BendamustineDrug

    Administered intravenously

  • IdelalisibDrug

    Administered orally

  • RituximabDrug

    Administered intravenously

  • VenetoclaxDrug

    Administered orally

Study groups in NCT06846671
Study groupRoleWhat they receive
Arm A: Tacabrutideg monotherapyExperimentalParticipants will receive tacabrutideg once daily until any of the treatment discontinuation criteria are met
Receives: Drug: Tacabrutideg
Arm B: Investigator's ChoiceActive comparatorParticipants will receive investigator's choice of idelalisib plus rituximab for CLL only or bendamustine plus rituximab, or venetoclax plus rituximab retreatment.
Receives: Drug: Bendamustine; Drug: Idelalisib; Drug: Rituximab; Drug: Venetoclax

What is being measured

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

  1. Progression-Free Survival (PFS) by 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: Approximately 36 Months

Secondary outcomes (10)

  1. Overall Survival (OS)

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

    Measured: Approximately 36 Months

  2. Progression-Free Survival (PFS) in Participants with Prior Exposure to Noncovalent Bruton Tyrosine Kinase Inhibitor(s) (ncBTKi) by 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 iwCLL for participants with prior exposure to ncBTKi.

    Measured: Approximately 36 Months

  3. PFS by the Investigator Assessment

    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 the investigator using modified 2018 iwCLL criteria for participants with CLL and Lugano classification for participants with SLL

    Measured: Approximately 36 Months

  4. Overall Response Rate (ORR) by IRC and Investigator Assessment

    ORR is defined as the percentage of participants with best overall response of complete response (CR), complete response with incomplete bone marrow recovery (Cri), nodular partial remission (nPR), or partial response (PR) as assessed by the IRC or by the investigator.

    Measured: Approximately 36 Months

  5. Rate of Partial Response with Lymphocytosis (PR-L) or Higher Determined by IRC and by Investigator Assessment

    Rate of PR-L or higher is defined as the percentage of participants with a best overall response of CR, CRi, nPR, PR, or PR-L as assessed by the IRC or by the Investigator

    Measured: Approximately 36 Months

  6. Duration of Response (DOR) by IRC and Investigator Assessment

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

    Measured: Approximately 36 Months

  7. 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: Approximately 36 Months

  8. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

    Safety will be assessed by monitoring and recording of all treatment emergent adverse events (AEs) graded by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.

    Measured: Approximately 36 Months

  9. Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Questionnaire -Core 30 (EORTC QLQ-C30) Global Health Status/QoL (GHS) and Physical Functioning Scales

    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). Higher scores in GHS and functional scales indicate better quality of life.

    Measured: Approximately 24 Months

  10. Change from baseline in EORTC Quality of Life Questionnaire - Chronic Lymphocytic Leukemia Module 17 Items (QLQ-CLL17) Symptom Burden and Physical Condition Scales

    The symptom burden and physical condition will be measured by QLQ-CLL17. EORTC QLQ-CLL17 comprises 17 items grouped into 3 multi-item scales: 1) symptom burden, 2) physical condition/fatigue, and 3) worries/fears about health and functioning. Each question is rated using a 4-point response scale ("not at all," "a little," "quite a bit," and "very much") and the recall period for all items is the past 7 days. The scores of each subscale are calculated based on the EORTC's protocol and then transformed to a 0 to 100 scale. Higher scores represent higher levels of symptom burden, physical condition/fatigue, or worries/fears about health and functioning.

    Measured: Approximately 24 Months

Timeline

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

  1. First posted26 Feb 2025
  2. Study start10 Apr 2025
  3. Primary completion15 May 2028 (estimated)
  4. Study completion14 Feb 2030 (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
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06846671
Sponsor's protocol ID
BGB-16673-302
Other IDs
2024-518893-15-00
Acronym
CaDAnCe-302
Status last verified
Sep 2026
First submitted
21 Feb 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, Bendamustine and Idelalisib in people with CLL and Chronic Lymphocytic Leukemia, run by BeOne Medicines at 132 sites in 14 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 6 inclusion and 7 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 132 sites in United States, Japan, Brazil, Germany, Italy and 9 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) by Independent Review Committee (IRC) (time frame: Approximately 36 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 NCT06846671.

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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