18 and older, any sex, with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response Rate (ORR) Assessed by the InvestigatorPrimary· From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).
ORR is defined as the percentage of participants with a complete response (CR) / complete response with incomplete bone marrow recovery (CRi), nodular partial response (nPR) or partial response (PR) per investigator assessment.
Disease response was assessed in accordance with the 2008 criteria of the International Workshop on CLL (IWCLL), with modification for treatment-related lymphocytosis in participants with CLL and in accordance with the Lugano classification in participants with SLL.
Group
Value
95% CI
Zanubrutinib
83.5
79.0 – 87.3
Ibrutinib
74.2
69.0 – 78.8
ORR Assessed by the Independent Review Committee (IRC)Primary· From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).
ORR is defined as the percentage of participants with a complete response (CR) / complete response with incomplete bone marrow recovery (CRi), nodular partial response (nPR) or partial response (PR) assessed by a blinded independent review committee. Overall response was assessed by the IRC for the purpose of regulatory filing with the Food and Drug Administration (FDA).
Disease response was assessed in accordance with the 2008 criteria of the International Workshop on CLL (IWCLL), with modification for treatment-related lymphocytosis in participants with CLL and in accordance with the Lugano
Group
Value
95% CI
Zanubrutinib
86.2
82.0 – 89.8
Ibrutinib
75.7
70.7 – 80.3
Progression-free Survival (PFS) Assessed by the InvestigatorSecondary· From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).
PFS is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.
Group
Value
95% CI
Zanubrutinib
NA
34.3 – NA
Ibrutinib
34.2
33.3 – NA
Progression-free Survival Assessed by the Independent Review CommitteeSecondary· From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).
PFS is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.
Group
Value
95% CI
Zanubrutinib
NA
34.3 – NA
Ibrutinib
35.0
33.2 – 44.3
Percentage of Participants With Atrial Fibrillation or Atrial FlutterSecondary· From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).
Participants were considered as having an atrial fibrillation/flutter event if they had a treatment-emergent AE of either "atrial fibrillation" or "atrial flutter".
Group
Value
95% CI
Zanubrutinib
5.2
3.1 – 8.3
Ibrutinib
13.3
9.8 – 17.5
Duration of Response Assessed by the Independent Review CommitteeSecondary· From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).
DOR is defined as the time from the date that response criteria were first met to the date that disease progression was objectively documented or death, whichever occurred first, determined by independent central review. Median DOR was estimated using the Kaplan-Meier method.
Group
Value
95% CI
Zanubrutinib
NA
31.3 – NA
Ibrutinib
33.9
32.2 – 41.4
Duration of Response (DOR) Assessed by the InvestigatorSecondary· From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).
DOR is defined as the time from the date that response criteria were first met to the date that disease progression was objectively documented or death, whichever occurred first, determined by investigator assessment. Median DOR was estimated using the Kaplan-Meier method.
Group
Value
95% CI
Zanubrutinib
NA
31.3 – NA
Ibrutinib
33.9
33.9 – NA
Time to Treatment FailureSecondary· From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).
Time to treatment failure is defined as the time from randomization to discontinuation of study drug due to any reason. Median time to treatment failure was estimated by the Kaplan-Meier method.
Group
Value
95% CI
Zanubrutinib
NA
NA – NA
Ibrutinib
NA
34.4 – NA
Rate of Partial Response With Lymphocytosis (PR-L) or Higher Assessed by the Independent Review CommitteeSecondary· From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).
The rate of partial response with lymphocytosis or better is defined as the percentage of participants who achieved a complete response or a complete response with incomplete bone marrow recovery (CR/CRi), nodular partial response, partial response, or partial response with lymphocytosis assessed by the blinded IRC.
Disease response was assessed per iwCLL 2008 criteria, with modification for treatment-related lymphocytosis for participants with CLL and per Lugano classification for participants with SLL.
Group
Value
95% CI
Zanubrutinib
91.7
88.2 – 94.5
Ibrutinib
83.1
78.5 – 87.0
Rate of Partial Response With Lymphocytosis (PR-L) or Higher Assessed by the InvestigatorSecondary· From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).
The rate of partial response with lymphocytosis or better is defined as the percentage of participants who achieved a complete response or complete response with incomplete bone marrow recovery (CR/CRi), nodular partial response, partial response, or partial response with lymphocytosis as assessed by the investigator.
Disease response was assessed according to the iwCLL 2008 criteria, with modification for treatment-related lymphocytosis for participants with CLL and in accordance with Lugano classification for participants with SLL.
Partial response with lymphocytosis: blood lymphocytes dec
Group
Value
95% CI
Zanubrutinib
89.9
86.1 – 93.0
Ibrutinib
82.5
77.9 – 86.4
Overall Survival (OS)Secondary· From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).
Overall survival is defined as the time from randomization to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method.
Group
Value
95% CI
Zanubrutinib
NA
NA – NA
Ibrutinib
NA
NA – NA
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL), Physical Functioning and Role Functioning ScoresSecondary· Baseline and Weeks 24 and 48
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) and 4 = Very Much (worst) and 2 global health quality of life
GHS/QoL Scale at Week 24
Group
Value
95% CI
Zanubrutinib
8.18
6.25 – 10.12
Ibrutinib
5.18
3.20 – 7.17
GHS/QoL Scale at Week 48
Group
Value
95% CI
Zanubrutinib
7.28
5.41 – 9.15
Ibrutinib
5.93
3.97 – 7.89
Physical Functioning Scale at Week 24
Group
Value
95% CI
Zanubrutinib
6.55
4.96 – 8.15
Ibrutinib
4.73
3.08 – 6.38
Physical Functioning Scale at Week 48
Group
Value
95% CI
Zanubrutinib
5.46
3.87 – 7.04
Ibrutinib
4.31
2.65 – 5.97
Role Functioning Scale at Week 24
Group
Value
95% CI
Zanubrutinib
6.95
4.85 – 9.06
Ibrutinib
6.32
4.14 – 8.50
Role Functioning Scale at Week 48
Group
Value
95% CI
Zanubrutinib
6.81
4.61 – 9.02
Ibrutinib
5.01
2.69 – 7.33
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm..
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Zanubrutinib
Serious: 172/324 (53%)
Deaths: 69/327
Ibrutinib
Serious: 196/324 (60%)
Deaths: 83/325
Serious adverse events (299 terms)
Reaction
System
Zanubrutinib
Ibrutinib
COVID-19 pneumonia
Infections and infestations
—
—
Pneumonia
Infections and infestations
—
—
COVID-19
Infections and infestations
—
—
Atrial fibrillation
Cardiac disorders
—
—
Urinary tract infection
Infections and infestations
—
—
Anaemia
Blood and lymphatic system disorders
—
—
Pyrexia
General disorders
—
—
Death
General disorders
—
—
Sepsis
Infections and infestations
—
—
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Cardiac arrest
Cardiac disorders
—
—
Myocardial infarction
Cardiac disorders
—
—
Constipation
Gastrointestinal disorders
—
—
Inguinal hernia
Gastrointestinal disorders
—
—
Bronchitis
Infections and infestations
—
—
Cellulitis
Infections and infestations
—
—
Herpes zoster
Infections and infestations
—
—
Lower respiratory tract infection
Infections and infestations
—
—
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Cerebrovascular accident
Nervous system disorders
—
—
Syncope
Nervous system disorders
—
—
Acute kidney injury
Renal and urinary disorders
—
—
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
Pleural effusion
Respiratory, thoracic and mediastinal disorders
—
—
Other adverse events (101 terms — click to expand)
This study is designed to compare the overall response rate of zanubrutinib versus ibrutinib in participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07341191 — Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR
· Phase 2
· not yet recruiting
NCT06859008 — Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Rel
· Phase 1
· recruiting
NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel
· Phase 3
· recruiting
NCT07321652 — Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated C
· Phase 3
· not yet recruiting
NCT07283965 — Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies
· not yet recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BeiGene
Last refreshed: 30 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03734016.