A Phase 3 interventional study of Sonrotoclax and Obinutuzumab in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by BeOne Medicines. Recruiting at 195 sites in 21 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by BeOne Medicines · Phase 3, Interventional, and Treatment
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Among 11 studies testing sonrotoclax in Leukemia, Lymphocytic, Chronic, B-Cell — 8 open to participants now, 11 under way, 4 of them phase 3. sonrotoclax · Leukemia, Lymphocytic, Chronic, B-Cell.
Among the 11 studies testing sonrotoclax in Leukemia, Lymphocytic, Chronic, B-Cell, this one is the 2nd largest by planned enrollment, is one of 3 that started in 2025, is one of 4 in phase 3, reaches primary completion later than 6 of the 10 other live ones, and was the 7th registered.
2,036 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 237 are open to participants now.
Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →8 of the 11 studies testing sonrotoclax in Leukemia, Lymphocytic, Chronic, B-Cell are open now, in 12 countries. Recruiting first, the newest first:
Alliance for Clinical Trials in Oncology · Sites in United States
Ages 65+
BeOne Medicines · Sites in United States, Australia, Brazil and 14 more countries
Ages 18+
City of Hope Medical Center · Sites in United States
Ages 18+
BeOne Medicines · Sites in United States, Australia, Brazil and 3 more countries
Ages 18+
City of Hope Medical Center · Sites in United States
Ages 18+
By country, each count listing its studies:
sonrotoclax: first FDA approval 2026 (BEQALZI). What it is approved for, and how studies give it, is on its page →
Of the 188 Leukemia, Lymphocytic, Chronic, B-Cell studies recruiting now, 150 (80%) set no upper age limit and 15 (8%) stop at 75 or younger; 17 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 6 · Phase 3 4
First in 2022; this study’s year is marked. 3 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 630 is above the median of 39 across 1,603 interventional studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.
Median enrollment 100 across the 11 interventional studies. None of them has completed or been terminated yet.
This tab as a report to print or save as PDF → With an account.
6 of 11 have an industry lead sponsor. The 6 most frequent:
BeOne Medicines is the lead sponsor of 69 studies on the registry; 49 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
18 studies in Leukemia, Lymphocytic, Chronic, B-Cell by BeOne Medicines: 7 open now, 12 under way, 7 of them phase 3. Of 6 finished, 3 (50%) have results posted.
Among the 18 studies in Leukemia, Lymphocytic, Chronic, B-Cell by BeOne Medicines, this one is the 4th largest by planned enrollment, is one of 5 that started in 2025, is one of 8 in phase 3, reaches primary completion later than 7 of the 11 other live ones, and was the 15th registered.
BeOne Medicines’s Leukemia, Lymphocytic, Chronic, B-Cell studies by the year they started, since 2017.
2 of the studies testing sonrotoclax in Leukemia, Lymphocytic, Chronic, B-Cell that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06637501BeOne MedicinesA Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia | 2026-11 |
| NCT07674810M.D. Anderson Cancer CenterA Phase 2 Trial Of The Combination Of Zanubrutinib, Sonrotoclax, And Obinutuzumab For Patients With Treatment-Naïve Chronic Lymphocytic Leukemia | 2027-04-30 |
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Among the 11 studies testing sonrotoclax in Leukemia, Lymphocytic, Chronic, B-Cell, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among BeOne Medicines’s 18 in Leukemia, Lymphocytic, Chronic, B-Cell:
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The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with R/R CLL/SLL. The safety of these treatments will also be assessed.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sonrotoclax and obinutuzumab will be administered in combination.
Drug: Sonrotoclax · Drug: Obinutuzumab
Sonrotoclax and rituximab will be administered in combination.
Drug: Sonrotoclax · Drug: Rituximab
Sonrotoclax and obinutuzumab will be administered in combination with treatment guided by evaluation of minimal residual disease (MRD).
Drug: Sonrotoclax · Drug: Obinutuzumab
Venetoclax and rituximab will be administered in combination.
Drug: Rituximab · Drug: Venetoclax
Administered orally
Also known as: BGB-11417
Administered intravenously
Also known as: Gazyva
Administered intravenously
Also known as: Rituxan
Administered Orally
Also known as: Venclexta
Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) for Arm A versus Arm D
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.
Time frame: Up to approximately 51 months
Progression-Free Survival (PFS) as assessed by BIRC for Arm B versus Arm D
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.
Time frame: Up to approximately 69 months
Rate of uMRD4 for Arm A versus Arm D
The rate of undetectable minimal residual disease (uMRD4) in peripheral blood based on next-generation sequencing (NGS)
Time frame: Up to approximately 12 months
Complete Response Rate as assessed by BIRC for Arm A versus Arm D
Complete Response Rate (CRR) is defined as the percentage of participants that achieve a best response of complete response (CR) or complete response with incomplete hematopoietic recovery (CRi)
Time frame: Up to approximately 25 months
Overall Survival for Arm A versus Arm D
Overall survival (OS) is defined as the time from the date of randomization to the date of death
Time frame: Up to approximately 84 months
PFS per Investigator Assessment (INV) for Arm B versus Arm D
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.
Time frame: Up to approximately 69 months
CRR per BIRC and by INV for Arm B versus Arm D
CRR is defined as the percentage of participants that achieve a best response of CR or CRi
Time frame: Up to approximately 25 months
OS for Arm B versus Arm D
OS is defined as the time from the date of randomization to the date of death
Time frame: Up to approximately 84 months
Rate of uMRD4 for Arm B versus Arm D
The rate of uMRD4 in peripheral blood based on NGS
Time frame: Up to approximately 25 months
PFS per BIRC and by INV for Arm A versus Arm B
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.
Time frame: Up to approximately 69 months
CRR per BIRC and by INV for Arm A versus Arm B
CRR is defined as the percentage of participants that achieve a best response of CR or CRi
Time frame: Up to approximately 25 months
OS for Arm A versus Arm B
OS is defined as the time from the date of randomization to the date of death
Time frame: Up to approximately 84 months
Rate of uMRD4 for Arm A versus Arm B
The rate of uMRD4 in peripheral blood based on NGS
Time frame: Up to approximately 25 months
Rate of uMRD4 for Arm A versus Arm D
The rate of uMRD4 in peripheral blood based on NGS
Time frame: Up to approximately 25 months
CRR per INV for Arm A versus Arm D
CRR is defined as the percentage of participants that achieve a best response of CR or CRi
Time frame: Up to approximately 25 months
PFS per INV for Arm A versus Arm D
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.
Time frame: Up to approximately 51 months
PFS per INV for Arm C versus Arm D
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.
Time frame: Up to approximately 69 months
CRR per INV for Arm C versus Arm D
CRR is defined as the percentage of participants that achieve a best response of CR or CRi
Time frame: Up to approximately 25 months
OS for Arm C versus Arm D
OS is defined as the time from the date of randomization to the date of death
Time frame: Up to approximately 84 months
Rate of uMRD4 for Arm C versus Arm D
The rate of uMRD4 in peripheral blood based on NGS
Time frame: Up to approximately 25 months
Overall Response Rate (ORR) per BIRC and by INV
ORR is defined as the percentage of participants that achieve a best response of partial response (PR) or better
Time frame: Up to approximately 25 months
Duration of Response (DOR) per BIRC and by INV
DOR is defined as the time from the date that response criteria were first met to the date of first documentation of disease progression or death, whichever occurs first
Time frame: Up to approximately 69 months
Time to Response (TTR) per BIRC and by INV
TTR is defined as the time from the date of randomization to the date response criteria were first met
Time frame: Up to approximately 25 months
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
Time frame: Up to approximately 84 months
Rate of uMRD4
The rate of uMRD4 in peripheral blood based on NGS
Time frame: Up to approximately 25 months
Change from Baseline in the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Global Health Status/Quality of Life 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 global health status (GHS) and functional scales indicate better health-related quality of life (HRQoL).
Time frame: Baseline and up to approximately 69 months
Change from Baseline in EORTC QLQ for Chronic Lymphocytic Leukemia (EORTC QLQ-CLL17) Symptom Burden and Fatigue Scales
The EORTC QLQ-CLL17 is the CLL module of QLQ-C30 consisting of 17 items and comprising 3 scales: symptom burden due to disease and/or treatment (6 items), physical condition/fatigue (4 items), and worries/fears about health and functioning (7 items) Items are 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. Lower scores indicate better HRQoL.
Time frame: Baseline and up to approximately 69 months
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Number of participants with TEAEs, including laboratory values, vital signs, 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 of sonrotoclax or venetoclax, or 90 days after the last dose of obinutuzumab or rituximab; up to approximately 26 months
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Showing the first 100 of 195 sites across 21 countries. Choose a country and city above to see the rest.
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, Statistical analysis plan, Clinical study report
Time frame: See plan description
Access criteria: See plan description
Data sharing details ↗ · beonemedicines.com
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Sep 2029, 51 months after the start.
Of 57 industry-sponsored phase 3 interventional studies under Leukemia, Lymphocytic, Chronic, B-Cell, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 73. This study's planned 51 months is close to that.
Counting every sponsor, half of 83 studies reached it within 59 months; a quarter within 43 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Sonrotoclax · Obinutuzumab · Rituximab
Leukemia, Lymphocytic, Chronic, B-Cell →