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Chronic Lymphocytic LeukemiaPhase 3CaDAnCe-303NCT06970743

A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors

A Phase 3 study testing BGB-16673, Bendamustine and Rituximab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by BeOne Medicines at 56 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (bendamustine plus rituximab or high-dose methylprednisolone plus rituximab or chlorambucil plus obinutuzumab) in participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BGB-16673, Bendamustine and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
56 sitesin 2 countries
Study dates
29 May 2025to 30 Nov 2029
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/SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
  • Previously received treatment for CLL/SLL with a covalent BTKi.
  • Measurable disease by computer tomography/magnetic resonance imaging for patients with SLL.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate bone marrow function
  • Adequate kidney and liver function
  • Adequate blood clotting function

Who cannot join

  • Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
  • 2. Prior autologous stem cell transplant (unless ≥ 3 months after transplant) or chimeric antigen receptor-T cell (unless ≥ 6 months after cell infusion)
  • History of severe allergic reactions or hypersensitivity to the active ingredient and excipients of study treatment (BGB-16673, bendamustine, rituximab, chlorambucil, or obinutuzumab)
  • Current or history of central nervous system involvement
  • History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug
  • History of confirmed progressive multifocal leukoencephalopathy.
Show all 9Show fewer
  • 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

56 sites in 2 countries.

56 sites in 2 countries

China53 sites

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100000

  • Peking University Peoples Hospital

    Beijing, Beijing Municipality, 100044

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • Binzhou Medical University Hospital

    Binzhou, Shandong, 256603

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • The First Peoples Hospital of Changde City

    Changde, Hunan, 415000

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, Sichuan, 610071

  • Chongqing University Three Gorges Central Hospital

    Chongqing, Chongqing Municipality, 404000

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 630014

  • Affiliated Zhongshan Hospital of Dalian University

    Dalian, Liaoning, 116001

  • Deyangs People Hospital

    Deyang, Sichuan, 618000

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510000

  • Sun Yat Sen University Cancer Center Huangpu Branch

    Guangzhou, Guangdong, 510555

  • Guizhou Provincial Peoples Hospital

    Guiyang, Guizhou, 550002

  • The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

    Hangzhou, Zhejiang, 310002

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicineqiantang Branch

    Hangzhou, Zhejiang, 310018

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • The First Affiliated Hospital of Harbin Medical Universitynangang Branch

    Harbin, Heilongjiang, 150001

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230000

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272000

  • The First Peoples Hospital of Yunnan Province

    Kunming, Yunnan, 650034

  • Linyi Cancer Hospital

    Linyi, Shandong, 276001

  • Lishui Central Hospital

    Lishui, Zhejiang, 323000

  • Meizhou People Hospital

    Meizhou, Guangdong, 514031

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 201203

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

  • Shenzhen Nanshan Peoples Hospital

    Shenzhen, Guangdong, 518052

  • Taihe Hospital

    Shiyan, Hubei, 442000

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • Taian City Central Hospital

    Taian, Shandong, 271099

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032

  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch

    Tianjin, Tianjin Municipality, 301617

  • Peoples Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang, 830001

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

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

    Wuhan, Hubei, 430022

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

    Wuhan, Hubei, 430030

  • Qinghai University Affiliated Hospital

    Xining, Qinghai, 810001

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, 453100

  • Xuchang Central Hospitalluminghu Branch

    Xuchang, Henan, 461000

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

  • The Second Peoples Hospital of Yibin

    Yibin, Sichuan, 644000

  • Yichang Central Peoples Hospital

    Yichang, Hubei, 443003

  • Red Cross Hospital of Yulin City

    Yulin, Guangxi, 537000

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

  • Henan Provincial Peoples Hospital

    Zhengzhou, Henan, 450003

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

Taiwan3 sites

  • Chang Bing Show Chwan Memorial Hospital

    Changhua, 505029

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, 704

Other trials in Taiwan

About this study

Official title: A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent BTK Inhibitors

The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (bendamustine plus rituximab or high-dose methylprednisolone plus rituximab or chlorambucil plus obinutuzumab) in participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to covalent Bruton tyrosine kinase inhibitor(s) (cBTKi).

Read the detailed description

Chronic lymphocytic leukemia and small lymphocytic lymphoma are types of blood cancer that affects people around the world. People with CLL and SLL 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 R/R CLL or SLL who were previously exposed to a covalent BTKi will receive BGB-16673 or the investigator's choice of bendamustine plus rituximab or high-dose methylprednisolone plus rituximab or chlorambucil plus obinutuzumab. 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 BGB-16673 versus the investigator's choice of treatment. Approximately 150 participants will be included in this study in Mainland China and Taiwan. Participants will be randomly allocated to receive either BGB-16673 or the investigator's choice of treatment.

Being tested
BGB-16673, Bendamustine, Rituximab, Methylprednisolone, Chlorambucil
Keywords
CLL, SLL, BTK-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.

  • BGB-16673Drug

    Also called Tacabrutideg

    Administered orally

  • BendamustineDrug

    Administered intravenously

  • RituximabDrug

    Administered intravenously

  • MethylprednisoloneDrug

    Administered intravenously

  • ChlorambucilDrug

    Administered orally

  • ObinutuzumabDrug

    Administered intravenously

Study groups in NCT06970743
Study groupRoleWhat they receive
Arm A: BGB-16673 MonotherapyExperimentalParticipants will receive BGB-16673 once daily until any of the treatment discontinuation criteria are met
Receives: Drug: BGB-16673
Arm B: Investigator's ChoiceActive comparatorParticipants will receive investigator's choice of bendamustine plus rituximab or high-dose methylprednisolone plus rituximab or chlorambucil plus obinutuzumab for up to six 28-day cycles. Participants with unequivocal disease progression confirmed by Independent Review Committee (IRC) may cross over to receive treatment with BGB-16673 at the Investigator's discretion
Receives: Drug: BGB-16673; Drug: Bendamustine; Drug: Rituximab; Drug: Methylprednisolone; Drug: Chlorambucil; Drug: Obinutuzumab

What is being measured

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

  1. Progression-Free Survival (PFS) 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 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with R/R CLL and the Lugano Classification for patients with R/R SLL.

    Measured: Approximately 23 Months

Secondary outcomes (10)

  1. PFS as Assessed by the Investigator

    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 the Lugano Classification for patients with R/R SLL.

    Measured: Approximately 12 Months

  2. Overall Survival (OS)

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

    Measured: Approximately 21 Months

  3. 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 23 Months

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

    Rate of PR-L or higher is defined as the percentage of participants with a best overall response of complete response (CR), complete response with incomplete bone marrow recovery (Cri), nodular partial remission (nPR), partial response (PR), or partial response with lymphocytosis (PR-L) as assessed by the Investigator.

    Measured: Approximately 23 Months

  5. 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 9 Months

  6. Time to Response (TTR) by IRC and Investigator Assessment

    TTR is defined as the time from randomization until initial response, as assessed by the IRC or by the investigator.

    Measured: Approximately 6 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 14 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) and laboratory abnormalities graded by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.

    Measured: Approximately 14 Months

  9. Change from baseline in European Organization of Research and Treatment of Cancer (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: Baseline and up to approximately 23 Months

  10. 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 (GHS)/Quality of Life (QoL) 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). The scores of each subscale are calculated based on the EORTC's protocol and then transformed to a 0 to 100 scale. Higher scores in GHS and functional scales indicate better quality of life.

    Measured: Baseline and up to approximately 23 Months

Timeline

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

  1. First posted14 May 2025
  2. Study start29 May 2025
  3. Primary completion30 Nov 2029 (estimated)
  4. Study completion30 Nov 2029 (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
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06970743
Sponsor's protocol ID
BGB-16673-303
Acronym
CaDAnCe-303
Status last verified
Aug 2026
First submitted
6 May 2025
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
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 BGB-16673, Bendamustine and Rituximab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by BeOne Medicines at 56 sites in 2 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in China, Taiwan. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) by IRC (time frame: Approximately 23 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 NCT06970743.

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 24 Aug 2026.

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