A Phase 3 interventional study of Sonrotoclax and Zanubrutinib in Mantle Cell Lymphoma and B Cell Lymphoma, sponsored by BeOne Medicines. Recruiting at 155 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by BeOne Medicines · Phase 3, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sonrotoclax and zanubrutinib will be administered in combination.
Drug: Sonrotoclax · Drug: Zanubrutinib
Placebo and zanubrutinib will be administered in combination.
Drug: Zanubrutinib · Drug: Placebo
Administered orally
Also known as: BGB-11417
Administered orally
Also known as: Brukinsa, BGB-3111
Administered orally
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.
Time frame: Approximately 41 months
Overall Survival (OS)
OS is defined as the time from randomization to the date of death from any cause.
Time frame: Approximately 92 months
PFS as assessed by investigator (INV)
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.
Time frame: Approximately 58 months
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.
Time frame: Approximately 58 months
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.
Time frame: Approximately 58 months
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.
Time frame: Approximately 58 months
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.
Time frame: Approximately 58 months
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.
Time frame: Approximately 58 months
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.
Time frame: Approximately 58 months
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).
Time frame: Approximately 58 months
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.
Time frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 58 months
Showing the first 100 of 155 sites across 17 countries.
Plan to share: 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.
Supporting information: Study protocol, Sap, Csr
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